Sample records for ophthalmic drugs advisory
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76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting
2011-05-24
... committee will discuss biologics license application (BLA) 125387, aflibercept ophthalmic solution, proposed...] Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration...: Dermatologic and Ophthalmic Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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2010-09-08
... Ophthalmic Solution AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment... acetate ophthalmic solution. This action is being taken to comply with the Federal Food, Drug, and... GENTOCIN DURAFILM (gentamicin sulfate and betamethasone acetate) Ophthalmic Solution, sponsored by Intervet...
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Ophthalmic Drug Dosage Forms: Characterisation and Research Methods
Baranowski, Przemysław; Karolewicz, Bożena; Gajda, Maciej; Pluta, Janusz
2014-01-01
This paper describes hitherto developed drug forms for topical ocular administration, that is, eye drops, ointments, in situ gels, inserts, multicompartment drug delivery systems, and ophthalmic drug forms with bioadhesive properties. Heretofore, many studies have demonstrated that new and more complex ophthalmic drug forms exhibit advantage over traditional ones and are able to increase the bioavailability of the active substance by, among others, reducing the susceptibility of drug forms to...
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Ophthalmic Drug Dosage Forms: Characterisation and Research Methods
Directory of Open Access Journals (Sweden)
Przemysław Baranowski
2014-01-01
Full Text Available This paper describes hitherto developed drug forms for topical ocular administration, that is, eye drops, ointments, in situ gels, inserts, multicompartment drug delivery systems, and ophthalmic drug forms with bioadhesive properties. Heretofore, many studies have demonstrated that new and more complex ophthalmic drug forms exhibit advantage over traditional ones and are able to increase the bioavailability of the active substance by, among others, reducing the susceptibility of drug forms to defense mechanisms of the human eye, extending contact time of drug with the cornea, increasing the penetration through the complex anatomical structure of the eye, and providing controlled release of drugs into the eye tissues, which allows reducing the drug application frequency. The rest of the paper describes recommended in vitro and in vivo studies to be performed for various ophthalmic drugs forms in order to assess whether the form is acceptable from the perspective of desired properties and patient’s compliance.
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Ophthalmic Drug Delivery Systems for Antibiotherapy—A Review
Dubald, Marion; Bourgeois, Sandrine; Andrieu, Véronique; Fessi, Hatem
2018-01-01
The last fifty years, ophthalmic drug delivery research has made much progress, challenging scientists about the advantages and limitations of this drug delivery approach. Topical eye drops are the most commonly used formulation in ocular drug delivery. Despite the good tolerance for patients, this topical administration is only focus on the anterior ocular diseases and had a high precorneal loss of drugs due to the tears production and ocular barriers. Antibiotics are popularly used in solution or in ointment for the ophthalmic route. However, their local bioavailability needs to be improved in order to decrease the frequency of administrations and the side effects and to increase their therapeutic efficiency. For this purpose, sustained release forms for ophthalmic delivery of antibiotics were developed. This review briefly describes the ocular administration with the ocular barriers and the currently topical forms. It focuses on experimental results to bypass the limitations of ocular antibiotic delivery with new ocular technology as colloidal and in situ gelling systems or with the improvement of existing forms as implants and contact lenses. Nanotechnology is presently a promising drug delivery way to provide protection of antibiotics and improve pathway through ocular barriers and deliver drugs to specific target sites. PMID:29342879
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Ophthalmic Drug Delivery Systems for Antibiotherapy—A Review
Directory of Open Access Journals (Sweden)
Marion Dubald
2018-01-01
Full Text Available The last fifty years, ophthalmic drug delivery research has made much progress, challenging scientists about the advantages and limitations of this drug delivery approach. Topical eye drops are the most commonly used formulation in ocular drug delivery. Despite the good tolerance for patients, this topical administration is only focus on the anterior ocular diseases and had a high precorneal loss of drugs due to the tears production and ocular barriers. Antibiotics are popularly used in solution or in ointment for the ophthalmic route. However, their local bioavailability needs to be improved in order to decrease the frequency of administrations and the side effects and to increase their therapeutic efficiency. For this purpose, sustained release forms for ophthalmic delivery of antibiotics were developed. This review briefly describes the ocular administration with the ocular barriers and the currently topical forms. It focuses on experimental results to bypass the limitations of ocular antibiotic delivery with new ocular technology as colloidal and in situ gelling systems or with the improvement of existing forms as implants and contact lenses. Nanotechnology is presently a promising drug delivery way to provide protection of antibiotics and improve pathway through ocular barriers and deliver drugs to specific target sites.
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Nagai, Noriaki
2016-01-01
The ophthalmic application of drugs is the primary route of administration for the therapy of glaucoma; however, in traditional formulations, only small amounts of the administered drug penetrate the cornea to reach the desired intraocular tissue due to corneal barriers. Recently, nanoparticulate drug delivery is expected as a technology to overcome the difficulties in delivering drugs across biological barriers (improvement of bioavailability). In this study, we attempted to establish a new method for preparing solid drug nanoparticles by using a bead mill and various additives, and succeeded in preparing a high quality dispersion containing drug nanoparticles. For a more concrete example, a mean particle size of disulfiram (DSF) treated with bead mill is 183 nm. The corneal penetration and corneal residence time of DSF from the ophthalmic dispersion containing DSF nanoparticles were significantly higher than those from a 2-hydroxypropyl-β-cyclodextrin solution containing DSF (DSF solution). It is known that the administration of DSF has intraocular pressure (IOP)-reducing effects. The IOP-reducing effects of the ophthalmic dispersion containing DSF nanoparticles were significantly greater than those of the DSF solution in rabbits (the IOP was enhanced by placing the rabbits in a dark room for 5 h). In addition, the ophthalmic dispersion containing DSF nanoparticles is better tolerated by corneal epithelial cells than DSF solution. It is possible that dispersions containing DSF nanoparticles provide new possibilities for effectively treating glaucoma, and that ocular drug delivery systems using drug nanoparticles may expand their usage for therapy in the ophthalmologic field.
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Nagel, Stefan; Guthoff, Rudolf F.; Weitschies, Werner; Seidlitz, Anne; Kristl, Albin; Žakelj, Simon; Loch, Christian
2015-01-01
To treat ophthalmic diseases like glaucoma or inflammatory disorders topically applied ophthalmic formulations such as eye drops are usually used. In addition, novel ophthalmic implants releasing drug substances locally into different parts of the eye are available today. In the work presented here, the permeability coefficients of selected drugs (ciprofloxacin hydrochloride, lidocaine hydrochloride, timolol maleate) for ophthalmic tissues were determined using side-by-side diffusion chambers...
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2013-02-25
...] Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee... be open to the public. Name of Committees: Medical Imaging Drugs Advisory Committee and the Oncologic... Special Medical Programs. [FR Doc. 2013-04141 Filed 2-22-13; 8:45 am] BILLING CODE 4160-01-P ...
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76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment
2011-07-29
.... FDA-2010-N-0002] Advisory Committee; Medical Imaging Drugs Advisory Committee; Re- Establishment... (FDA) is announcing the re- establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging...
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Advisory Board on Alcoholism and Drug Abuse
State Employees Advisory Board on Alcoholism and Drug Abuse DHSS State of Alaska Home Divisions and ; Advisory Board on Alcoholism and Drug Abuse Page Content Alison Kulas Executive Director If you, a family Kulas Begins Tenure as Executive Director The Advisory Board on Alcoholism and Drug Abuse, The Alaska
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2012-11-21
... Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National Cancer Advisory Board... Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National...: National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and...
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75 FR 81283 - Oncologic Drugs Advisory Committee; Cancellation
2010-12-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee scheduled for February 9, 2011, is...
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77 FR 63839 - Oncologic Drugs Advisory Committee; Cancellation
2012-10-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee Meeting scheduled for November 8, 2012, is...
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21 CFR 524.1982 - Proparacaine hydrochloride ophthalmic solution.
2010-04-01
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Proparacaine hydrochloride ophthalmic solution... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.1982 Proparacaine hydrochloride ophthalmic solution. (a) Specifications. The drug is...
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2013-04-04
... Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice... of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management... Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee...
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21 CFR 524.390b - Chloramphenicol ophthalmic solution.
2010-04-01
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Chloramphenicol ophthalmic solution. 524.390b... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.390b Chloramphenicol ophthalmic solution. (a) Specifications. Each milliliter contains 5...
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78 FR 17413 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2013-03-21
...] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... rescheduled due to the postponement of the March 7, 2013, Pulmonary-Allergy Drugs Advisory Committee meeting due to unanticipated weather conditions. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee...
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21 CFR 524.1044a - Gentamicin ophthalmic solution.
2010-04-01
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Gentamicin ophthalmic solution. 524.1044a Section... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.1044a Gentamicin ophthalmic solution. (a) Specifications. Each milliliter of sterile aqueous...
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75 FR 8377 - Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice
2010-02-24
...] Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS... of a meeting of the Pulmonary-Allergy Drugs Advisory Committee. This meeting was announced in the... February 2, 2010, FDA announced that a meeting of the Pulmonary-Allergy Drugs Advisory Committee would be...
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Basics of Sterile Compounding: Ophthalmic Preparations, Part 1: Ophthalmic Solutions.
Allen, Loyd V
2016-01-01
Ophthalmic preparations are used to treat allergies, bacterial and viral infections, glaucoma, and numerous other eye conditions. When the eye's natural defensive mechanisms are compromised or overcome, an ophthalmic preparation, in a solution, suspension, or ointment form, may be indicated, with solutions being the most common form used to deliver a drug to the eye. This article provides a general discussion on ophthalmic preparations and specifically discusses the preparation of solutions. Copyright© by International Journal of Pharmaceutical Compounding, Inc.
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21 CFR 524.1200b - Kanamycin ophthalmic aqueous solution.
2010-04-01
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Kanamycin ophthalmic aqueous solution. 524.1200b... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.1200b Kanamycin ophthalmic aqueous solution. (a) Specifications. The drug, which is in an aqueous...
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21 CFR 886.4790 - Ophthalmic sponge.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic sponge. 886.4790 Section 886.4790 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4790 Ophthalmic sponge. (a) Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton...
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21 CFR 886.4390 - Ophthalmic laser.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic laser. 886.4390 Section 886.4390 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4390 Ophthalmic laser. (a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin...
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2010-09-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug Safety... and Central Nervous System Drugs Advisory Committee and the Drug Safety and Risk Management Advisory...
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77 FR 50702 - Cardiovascular and Renal Drugs Advisory Committee; Cancellation
2012-08-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Cardiovascular and Renal Drugs Advisory Committee scheduled for...
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78 FR 57166 - Antiviral Drugs Advisory Committee; Notice of Meeting
2013-09-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 31025 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-05-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 58399 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-09-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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78 FR 13348 - Oncologic Drugs Advisory Committee; Notice of Meeting
2013-02-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 32125 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-05-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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75 FR 9419 - Oncologic Drugs Advisory Committee; Notice of Meeting
2010-03-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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78 FR 48690 - Oncologic Drugs Advisory Committee; Notice of Meeting
2013-08-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 5813 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-02-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 82309 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-12-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 11489 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-03-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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75 FR 16151 - Antiviral Drugs Advisory Committee; Notice of Meeting
2010-03-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 25184 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-04-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 44595 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-07-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 62418 - Antiviral Drugs Advisory Committee; Notice of Meeting
2011-10-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 82310 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-12-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 65736 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-10-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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75 FR 75680 - Oncologic Drugs Advisory Committee; Notice of Meeting
2010-12-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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Directory of Open Access Journals (Sweden)
Mária Budai-Szűcs
2018-02-01
Full Text Available Thiolated poly(aspartic acid is known as a good mucoadhesive polymer in aqueous ophthalmic formulations. In this paper, cyclodextrin-modified thiolated poly(aspartic acid was synthesized for the incorporation of prednisolone, a lipophilic ophthalmic drug, in an aqueous in situ gellable mucoadhesive solution. This polymer combines the advantages of cyclodextrins and thiolated polymers. The formation of the cyclodextrin-drug complex in the gels was analyzed by X-ray powder diffraction. The ocular applicability of the polymer was characterized by means of physicochemical, rheological and drug diffusion tests. It was established that the chemical bonding of the cyclodextrin molecule did not affect the complexation of prednisolone, while the polymer solution preserved its in situ gellable and good mucoadhesive characteristics. The chemical immobilization of cyclodextrin modified the diffusion profile of prednisolone and prolonged drug release was observed. The combination of free and immobilized cyclodextrins provided the best release profile because the free complex can diffuse rapidly, while the bonded complex ensures a prolonged action.
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2010-03-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide...
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21 CFR 886.1420 - Ophthalmic lens gauge.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic lens gauge. 886.1420 Section 886.1420...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1420 Ophthalmic lens gauge. (a) Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a...
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21 CFR 886.4230 - Ophthalmic knife test drum.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic knife test drum. 886.4230 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4230 Ophthalmic knife test drum. (a) Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical...
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21 CFR 886.5800 - Ophthalmic bar reader.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic bar reader. 886.5800 Section 886.5800...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5800 Ophthalmic bar reader. (a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a...
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21 CFR 886.1650 - Ophthalmic bar prism.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic bar prism. 886.1650 Section 886.1650...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1650 Ophthalmic bar prism. (a) Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing...
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21 CFR 886.4750 - Ophthalmic eye shield.
2010-04-01
...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4750 Ophthalmic eye shield. (a) Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic eye shield. 886.4750 Section 886.4750...
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77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2012-10-24
...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...
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78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2013-05-23
...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...
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78 FR 734 - Medical Imaging Drugs Advisory Committee; Notice of Meeting
2013-01-04
...] Medical Imaging Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Medical Imaging Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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75 FR 9420 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2010-03-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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76 FR 29766 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2011-05-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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77 FR 4566 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2012-01-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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77 FR 69635 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2012-11-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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75 FR 5334 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2010-02-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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75 FR 82031 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2010-12-29
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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77 FR 74486 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2012-12-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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77 FR 69636 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2012-11-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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75 FR 5333 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2010-02-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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78 FR 46976 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2013-08-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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2012-02-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public...
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21 CFR 886.4350 - Manual ophthalmic surgical instrument.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual ophthalmic surgical instrument. 886.4350 Section 886.4350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor...
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Loch, Christian; Zakelj, Simon; Kristl, Albin; Nagel, Stefan; Guthoff, Rudolf; Weitschies, Werner; Seidlitz, Anne
2012-08-30
To treat ophthalmic diseases like glaucoma or inflammatory disorders topically applied ophthalmic formulations such as eye drops are usually used. In addition, novel ophthalmic implants releasing drug substances locally into different parts of the eye are available today. In the work presented here, the permeability coefficients of selected drugs (ciprofloxacin hydrochloride, lidocaine hydrochloride, timolol maleate) for ophthalmic tissues were determined using side-by-side diffusion chambers (so-called Ussing chambers). Sclera, conjunctiva, cornea, choroidea-retina-complex and a complex of conjunctiva-sclera-choroidea-retina were excised from fresh porcine, rabbit and bovine eyes. In the porcine eye tissues the highest P(app) values were obtained for conjunctiva with the exception of lidocaine. Therefore, it can be estimated that a certain amount of drug diffuses or is transported through conjunctiva after application. The P(app) values for sclera were also higher than those for cornea and even more, the surface area of sclera which is available for drug absorption is much larger than that of cornea when applying an implant. The obtained permeability coefficients for sclera and conjunctiva indicate that the administration of periocular implants can be an alternative to topically applied formulations. The complexes of the tissues were a significantly (p<0.01) stronger barrier to the investigated substances than the separated tissues. Distinct differences in permeability coefficients between the investigated animal tissues were observed. Overall the highest P(app) values for all mounted tissues were obtained with the rabbit, followed by porcine and bovine eyes. Because of these distinct interspecies differences one must be very careful when selecting the proper animal model for the permeability experiments. Copyright © 2012 Elsevier B.V. All rights reserved.
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76 FR 81806 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution
2011-12-29
.... FDA-2011-N-0003] Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution... solution of ivermectin. DATES: This rule is effective December 29, 2011. FOR FURTHER INFORMATION CONTACT... ANADA 200-318 for [[Page 81807
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2011-09-23
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the...., [[Page 59143
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21 CFR 886.1410 - Ophthalmic trial lens clip.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens clip. 886.1410 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1410 Ophthalmic trial lens clip. (a) Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders, or...
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Marlowe, Zora T; Davio, Stephen R
2014-01-01
Loteprednol etabonate (LE) ophthalmic gel 0.5% (Lotemax®) is a new polycarbophil-based, nonsettling topical ophthalmic formulation. The formulation is a semisolid gel at rest and a shear thinning fluid when expressed through a dropper tip. The present study was undertaken to determine how the nonsettling character of LE ophthalmic gel affects dose uniformity. Prednisolone acetate ophthalmic suspension 1% (Pred Forte®) and a generic prednisolone acetate suspension 1% were used as comparators. Drug concentrations of LE ophthalmic gel, Pred Forte, and a generic prednisolone acetate suspension were determined following simulated dosing - consisting of 2 drops, expressed four times daily for 2 weeks, with bottles that were shaken or not shaken immediately prior to expressing the drops. Drug concentrations were determined using a reverse-phase high-performance liquid chromatography (HPLC) method and reported as a percentage of the declared (labeled) concentration. Comparative kinetics of drug particle sedimentation were also determined for each formulation, using dispersion analysis under gravity. Mean drug concentrations in drops of all three formulations were within a few percentage points of the declared concentration when the bottles were shaken for 5 seconds prior to dispensing. Only LE ophthalmic gel showed consistent and on-target concentrations when the bottles were unshaken prior to dispensing, with a mean (standard deviation [SD]) percent declared concentration of 102% (1.92%) over the 2-week dosing regimen. Drug concentrations for the branded and generic prednisolone acetate suspensions following expression from unshaken bottles were highly variable (overall relative SDs of 16.8% and 20.3%, respectively), with mean concentrations for both falling significantly below the declared concentration for drops expressed at the beginning of the 2-week dosing regimen and significantly above the declared concentration for drops expressed near the end of the dosing
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Directory of Open Access Journals (Sweden)
Marlowe ZT
2013-12-01
Full Text Available Zora T Marlowe, Stephen R DavioPharmaceutical Product Development, Global Pharmaceutical Research and Development, Bausch and Lomb, Inc, Rochester, NY, USAIntroduction: Loteprednol etabonate (LE ophthalmic gel 0.5% (Lotemax® is a new polycarbophil-based, nonsettling topical ophthalmic formulation. The formulation is a semisolid gel at rest and a shear thinning fluid when expressed through a dropper tip. The present study was undertaken to determine how the nonsettling character of LE ophthalmic gel affects dose uniformity. Prednisolone acetate ophthalmic suspension 1% (Pred Forte® and a generic prednisolone acetate suspension 1% were used as comparators.Methods: Drug concentrations of LE ophthalmic gel, Pred Forte, and a generic prednisolone acetate suspension were determined following simulated dosing – consisting of 2 drops, expressed four times daily for 2 weeks, with bottles that were shaken or not shaken immediately prior to expressing the drops. Drug concentrations were determined using a reverse-phase high-performance liquid chromatography (HPLC method and reported as a percentage of the declared (labeled concentration. Comparative kinetics of drug particle sedimentation were also determined for each formulation, using dispersion analysis under gravity.Results: Mean drug concentrations in drops of all three formulations were within a few percentage points of the declared concentration when the bottles were shaken for 5 seconds prior to dispensing. Only LE ophthalmic gel showed consistent and on-target concentrations when the bottles were unshaken prior to dispensing, with a mean (standard deviation [SD] percent declared concentration of 102% (1.92% over the 2-week dosing regimen. Drug concentrations for the branded and generic prednisolone acetate suspensions following expression from unshaken bottles were highly variable (overall relative SDs of 16.8% and 20.3%, respectively, with mean concentrations for both falling significantly
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21 CFR 886.1405 - Ophthalmic trial lens set.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens set. 886.1405 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1405 Ophthalmic trial lens set. (a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers...
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77 FR 12062 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2012-02-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee...
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Ding, Wenting; Ni, Weiling; Chen, Huilian; Yuan, Jingqun; Huang, Xiaodan; Zhang, Zheng; Wang, Yao; Yu, Yibo; Yao, Ke
2015-01-01
To investigate the penetration of 0.3% gatifloxacin ophthalmic gel, 0.3% gatifloxacin ophthalmic solution and 0.5% levofloxacin ophthalmic solution into aqueous humor after topical application. Age-related cataract patients (150 eyes in 150 cases) receiving phacoemulsification were randomly divided into three groups: a 0.3% gatifloxacin gel group (n=50), a 0.3% gatifloxacin solution group (n=50), and a 0.5% levofloxacin solution group (n=50). Each group was administered one drop of gel or solution every 15 minutes for four doses. Aqueous samples were collected at different time points after the last drop. High pressure liquid chromatography (HPLC) was applied to determine the concentrations. The one-way ANOVA analysis was performed. Our data indicated that the concentration of the gatifloxacin gel group was higher than that of the gatifloxacin solution group at all time points (P solution group at 120.0 min and 180.0 min (Psolutions reached their peak values at 60.0 min. 0.3% gatifloxacin ophthalmic gel application produced highest aqueous humor drug concentration, maintained the longest time, had the best penetration and bioavailability.
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2011-06-23
... Alcohol Abuse and Alcoholism and National Advisory Council on Drug Abuse; Notice of Joint Meeting Pursuant... given of a joint meeting of the National Advisory Council on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse. The meeting will be open to the public as indicated below, with...
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77 FR 43093 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2012-07-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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78 FR 38717 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2013-06-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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75 FR 35496 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-06-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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77 FR 43600 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2012-07-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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75 FR 1395 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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78 FR 36787 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2013-06-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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75 FR 52762 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-08-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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75 FR 30839 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-06-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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76 FR 82310 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2011-12-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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76 FR 39404 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2011-07-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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2011-07-11
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... East, Adelphi, MD. The conference center telephone number is: 301 985-7300. Contact Person: Kalyani...
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75 FR 70933 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-11-19
...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committees... appropriate clinical study design for thromboxane receptor antagonists for prevention of cardiovascular events...
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2013-01-14
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... before February 7, 2013. Time allotted for each presentation may be limited. If the number of registrants...
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2011-09-23
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the..., Adelphi, MD. The conference center telephone number is 301-985-7300. Contact Person: Kalyani Bhatt, Center...
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78 FR 76307 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2013-12-17
...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. FDA intends...
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21 CFR 524.1484e - Neomycin sulfate and polymyxin B sulfate ophthalmic solution.
2010-04-01
... ophthalmic solution. 524.1484e Section 524.1484e Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.1484e Neomycin sulfate and polymyxin B sulfate ophthalmic solution. (a...
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2013-03-14
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably...
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78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2013-12-17
...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and..., Inc., for the proposed indication to reduce the risk of thrombotic cardiovascular events in patients...
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75 FR 57474 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-09-21
...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... analyses of the TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) study of ARANESP...
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77 FR 21982 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2012-04-12
...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...., to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS...
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75 FR 26647 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution
2010-05-12
.... FDA-2010-N-0002] Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution... are treated with a topical solution of ivermectin. DATES: This rule is effective May 12, 2010. FOR... ANADA 200-340 for PRIVERMECTIN (ivermectin), a topical solution used on cattle to control infestations...
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75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2010-05-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...
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21 CFR 886.1415 - Ophthalmic trial lens frame.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens frame. 886.1415 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1415 Ophthalmic trial lens frame. (a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for vision...
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77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2012-12-19
...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug... being rescheduled due to the postponement of the October 29-30, 2012, Drug Safety and Risk Management... Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...
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2010-04-06
...] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory... Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was... Drug Safety and Risk Management Advisory Committee would be held on May 12, 2010. On page 10490, in the...
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21 CFR 524.1662 - Oxytetracycline hydrochloride ophthalmic and topical dosage forms.
2010-04-01
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Oxytetracycline hydrochloride ophthalmic and topical dosage forms. 524.1662 Section 524.1662 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DOSAGE FORM NEW ANIMAL DRUGS § 524.1662 Oxytetracycline hydrochloride ophthalmic and topical dosage forms. ...
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76 FR 44595 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2011-07-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee...
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[Biological availability of ophthalmic drugs. 1. Increasing drug permeability in the cornea].
Masteiková, R; Chalupová, Z; Savickiene, N
2004-03-01
Most eye diseases are treated by topical administration of ophthalmic preparations. Low ophthalmic bioavailability is due to a number of physiological and physicochemical factors. The main obstacle to the penetration of active ingredients to the eye is the layered character of the cornea. Formulation of ophthalmic preparations enabling easier penetration of this biological barrier thus ranks among the most effective ways of improving bioavailability. Penetrability of the cornea can be increased by the following methods: a) adjustment of the actual acidity in such a way that pH of the preparation makes it possible to produce the optimal portion of non-ionized particles; b) incorporation of absorption enhancers (non-ionic tensides, salts of bile acids, some antimicrobial substances, EDTA, cyclodextrins, etc.) into the composition of the preparation, and c) production of prodrugs or ionic pairs.
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75 FR 12768 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2010-03-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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78 FR 20328 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2013-04-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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78 FR 63478 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2013-10-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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75 FR 36428 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2010-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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77 FR 20037 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2012-04-03
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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76 FR 3912 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2011-01-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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75 FR 17417 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2010-04-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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78 FR 63481 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2013-10-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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IN-SITU OPHTHALMIC GELS FOR THE TREATMENT OF EYE DISEASES
M. Jothi, S.L. Harikumar* and Geeta Aggarwal
2012-01-01
Topical administration of a drug in the conjunctival cul-de-sac is the treatment of choice for diseases of the anterior segment of eye. Development of ophthalmic drug delivery systems has always been challenging because of the drawbacks with this route, like non-productive absorption, drainage, induced lacrimation, tear turn over, impermeability of drugs to cornea. New approaches have been investigated for delivery of drugs to the eye by means of polymeric delivery of ophthalmic drugs to the ...
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75 FR 75681 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2010-12-06
...] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...) and/or abnormal vascularity (abnormal blood supply and circulation) of the central nervous system. The...
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Qin, Fuhong; Zeng, Li; Zhu, Yongtao; Cao, Jingjing; Wang, Xiaohui; Liu, Wei
2016-01-01
The aim of this work was to assess the performance of resin as an ocular delivery system. Timolol maleate (TM) was chosen as the model drug and an ion exchange resin (IER) as the carrier. The drug-resin complex was prepared using an oscillation method and then characterized regarding particle size, zeta potential, morphology, and drug content. After in vitro drug release study and corneal permeation study were performed, in vivo studies were performed in New Zealand albino rabbits using a suspension with particles sized 4.8 ± 1.2 μm and drug loading at 43.00 ± 0.09%. The results indicate that drug released from the drug-resin ophthalmic suspension permeated the cornea and displayed a sustained-release behavior. Drug levels in the ocular tissues after administration of the drug-resin ophthalmic suspension were significantly higher than after treatment with an eye drop formulation but were lower in body tissues and in the plasma. In conclusion, resins have great potential as effective ocular drug delivery carriers to increase ocular bioavailability of timolol while simultaneously reducing systemic drug absorption.
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Ophthalmic gels: Past, present and future.
Al-Kinani, Ali A; Zidan, Ghada; Elsaid, Naba; Seyfoddin, Ali; Alani, Adam W G; Alany, Raid G
2018-02-15
Aqueous gels formulated using hydrophilic polymers (hydrogels) along with those based on stimuli responsive polymers (in situ gelling or gel forming systems) continue to attract increasing interest for various eye health-related applications. They allow the incorporation of a variety of ophthalmic pharmaceuticals to achieve therapeutic levels of drugs and bioactives at target ocular sites. The integration of sophisticated drug delivery technologies such as nanotechnology-based ones with intelligent and environment responsive systems can extend current treatment duration to provide more clinically relevant time courses (weeks and months instead of hours and days) which will inevitably reduce dose frequency, increase patient compliance and improve clinical outcomes. Novel applications and design of contact lenses and intracanalicular delivery devices along with the move towards integrating gels into various drug delivery devices like intraocular pumps, injections and implants has the potential to reduce comorbidities caused by glaucoma, corneal keratopathy, cataract, diabetic retinopathies and age-related macular degeneration. This review describes ophthalmic gelling systems with emphasis on mechanism of gel formation and application in ophthalmology. It provides a critical appraisal of the techniques and methods used in the characterization of ophthalmic preformed gels and in situ gelling systems along with a thorough insight into the safety and biocompatibility of these systems. Newly developed ophthalmic gels, hydrogels, preformed gels and in situ gelling systems including the latest in the area of stimuli responsive gels, molecularly imprinted gels, nanogels, 3D printed hydrogels; 3D printed devices comprising ophthalmic gels are covered. Finally, new applications of gels in the production of artificial corneas, corneal wound healing and hydrogel contact lenses are described. Copyright © 2017 Elsevier B.V. All rights reserved.
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75 FR 71450 - Oncologic Drugs Advisory Committee; Amendment of Notice
2010-11-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of a...
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77 FR 37911 - Oncologic Drugs Advisory Committee; Amendment of Notice
2012-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the...
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21 CFR 349.14 - Ophthalmic emollients.
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ophthalmic emollients. 349.14 Section 349.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR.... (4) Petrolatum, up to 100 percent. (5) White ointment, up to 100 percent. (6) White petrolatum, up to...
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2011-09-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General...
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21 CFR 349.12 - Ophthalmic demulcents.
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ophthalmic demulcents. 349.12 Section 349.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR....2 to 1 percent. (5) Propylene glycol, 0.2 to 1 percent. (e) Polyvinyl alcohol, 0.1 to 4 percent. (f...
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2011-11-16
...] Determination That TRAVATAN (Travoprost Ophthalmic Solution), 0.004%, Was Not Withdrawn From Sale for Reasons of... Drug Administration (FDA) has determined that TRAVATAN (travoprost ophthalmic solution), 0.004%, was... approve abbreviated new drug applications (ANDAs) for travoprost ophthalmic solution, 0.004%, if all other...
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76 FR 71349 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting
2011-11-17
.... Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration...) Appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of.... This will include a discussion of the definition and scope of this indication as well as the types of...
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2010-10-29
...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... or, are in late stage development for an adult oncology indication. The subcommittee will consider...
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2012-09-17
...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... that are in development for an adult oncology indication. The subcommittee will consider and discuss...
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2011-10-05
...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... adult oncology indication, or in late stage development in pediatric patients with cancer. The...
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2013-10-23
...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... oncology indications. The subcommittee will consider and discuss issues relating to the development of each...
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2013-10-23
...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... the public. Name of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory... measures in the pediatric development plans of oncology products. The half-day session will provide an...
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Paskiet, Diane; Jenke, Dennis; Ball, Douglas; Houston, Christopher; Norwood, Daniel L; Markovic, Ingrid
2013-01-01
The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that advances drug product quality and development. The collaborative activities of PQRI participants have, in the case of orally inhaled and nasal drug products (OINDPs), resulted in comprehensive and widely-accepted recommendations for leachables assessments to help ensure patient safety with respect to this class of packaged drug products. These recommendations, which include scientifically justified safety thresholds for leachables, represent a significant milestone towards establishing standardized approaches for safety qualification of leachables in OINDP. To build on the success of the OINDP effort, PQRI's Parenteral and Ophthalmic Drug Products (PODP) Leachables and Extractables Working Group was formed to extrapolate the OINDP threshold concepts and best practice recommendations to other dosage forms with high concern for interaction with packaging/delivery systems. This article considers the general aspects of leachables and their safety assessment, introduces the PODP Work Plan and initial study Protocol, discusses the laboratory studies being conducted by the PODP Chemistry Team, outlines the strategy being developed by the PODP Toxicology Team for the safety qualification of PODP leachables, and considers the issues associated with application of the safety thresholds, particularly with respect to large-volume parenterals. Lastly, the unique leachables issues associated with biologics are described. The Product Quality Research Institute (PQRI) is a non-profit consortium involving industry organizations, academia, and regulatory agencies that together provide recommendations in support of regulatory guidance to advance drug product quality. The collaborative activities of the PQRI Orally Inhaled and Nasal Drug Products Leachables and Extractables Working Group resulted in a
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Are we pharmacovigilant enough in ophthalmic practice?
Directory of Open Access Journals (Sweden)
Ashok Dubey
2013-01-01
Full Text Available No drug is absolutely safe. Pharmacovigilance is the science related to detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. The ocular medications and devices can cause localized and systemic adverse effects. Not all adverse effects are known when a drug or device is launched in market because of limitations of clinical trials. Many adverse effects are recognized due to the spontaneous reporting of the vigilant doctors who observe and report such events encountered in their practice. Despite a large ophthalmic patient population base, India does not have robust adverse drug reaction (ADR database because of lack of reporting culture. Government of India recently launched the Pharmacovigilance Programme of India (PvPI to monitor ADRs and create awareness among the healthcare professionals about the importance of ADRs. Suspecting and reporting a possible drug reaction is very important in developing a safe and rational ophthalmic practice.
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2010-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice...
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76 FR 70462 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting
2011-11-14
...] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Committee for Reproductive Health Drugs. General Function of the Committee: To provide advice and... be limited. If the number of registrants requesting to speak is greater than can be reasonably...
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78 FR 734 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting
2013-01-04
...] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Committee for Reproductive Health Drugs. General Function of the Committee: To provide advice and... limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated...
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2010-04-22
...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...
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Asasutjarit, Rathapon; Theerachayanan, Thitaree; Kewsuwan, Prartana; Veeranodha, Sukitaya; Fuongfuchat, Asira; Ritthidej, Garnpimol C
2015-10-01
The ophthalmic preparation of diclofenac sodium (DC) for relieving ocular inflammation is presently available in the market only as an eye drop solution. Due to its low occular bioavailability, it requires frequent application leading to low patients' compliance and quality of life. This study was conducted to develop formulations of DC loaded-N-trimethyl chitosan nanoparticles (DC-TMCNs) for ophthalmic use to improve ocular biavailabiltiy of DC. DC-TMCNs varied in formulation compositions were prepared using ionic gelation technique and evaluated for their physicochemical properties, drug release, eye irritation potential, and ophthalmic absorption of diclofenac sodium. N-Trimethyl chitosan (TMC) with a 49.8% degree of quaternization was synthesized and used for DC-TMCNs production. The obtained DC-TMCNs had particle size in a range of 130-190 nm with zeta potential values of +4 to +9 mV and drug entrapment efficiencies of more than 70% depending on the content of TMC and sodium tripolyphosphate (TPP). The optimized DC-TMCNs formulation contained TMC, DC, and TPP at a weight ratio of TMC/DC/TPP = 3:1:1. Their lyophilized product reconstituted with phosphate buffer solution pH 5.5 possessed a drug release pattern that fitted within the zero-order model. The eye irritation tests showed that DC-TMCNs were safe for ophthalmic use. The in vivo ophthalmic drug absorption study performed on rabbits indicated that DC-TMCNs could improve ophthalmic bioavailability of DC. Results of this study suggested that DC-TMCNs had potential for use as an alternative to conventional DC eye drops for ophthalmic inflammation treatment.
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Diquafosol ophthalmic solution for dry eye treatment.
Nakamura, Masatsugu; Imanaka, Takahiro; Sakamoto, Asuka
2012-07-01
There has been rapid progress in our understanding of dry eye pathogenesis, as well as the development of improved diagnostic clinical tests. Various types of dry eye treatment drugs have been developed. This review summarizes the basic and clinical research carried out in the development of diquafosol for ophthalmic use. Diquafosol is a dinucleotide, purinoreceptor P2Y(2) receptor agonist. Basic pharmacological studies have shown that it acts on P2Y(2) receptors at the ocular surface, to promote tear and mucin secretion via elevated intracellular Ca(2+) concentrations. Diquafosol also improves tear and mucin secretion in experimental dry eye models. Based on the results of laboratory experiments, the authors conducted a series of clinical studies in patients with dry eye disease. Diquafosol was effective in the treatment of dry eye disease at an optimal dose of 3% six times a day. In comparison to commercially available 0.1% sodium hyaluronate ophthalmic solution, 3% diquafosol ophthalmic solution showed non-inferiority in improving corneal fluorescein staining scores and superiority in improving keratoconjunctival Rose Bengal staining scores. Diquafosol ophthalmic solution has a novel mechanism of action that is characterized by its stimulatory effects on tear and mucin secretion. This drug has the potential to be effective in patients with tear film instability and short break-up time type of dry eye, which are essential factors in dry eye pathogenesis.
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Chitosan/alginate based multilayers to control drug release from ophthalmic lens.
Silva, Diana; Pinto, Luís F V; Bozukova, Dimitriya; Santos, Luís F; Serro, Ana Paula; Saramago, Benilde
2016-11-01
In this study we investigated the possibility of using layer-by-layer deposition, based in natural polymers (chitosan and alginate), to control the release of different ophthalmic drugs from three types of lens materials: a silicone-based hydrogel recently proposed by our group as drug releasing soft contact lens (SCL) material and two commercially available materials: CI26Y for intraocular lens (IOLs) and Definitive 50 for SCLs. The optimised coating, consisting in one double layer of (alginate - CaCl2)/(chitosan+glyoxal) topped with a final alginate-CaCl2 layer to avoid chitosan degradation by tear fluid proteins, proved to have excellent features to control the release of the anti-inflammatory, diclofenac, while keeping or improving the physical properties of the lenses. The coating leads to a controlled release of diclofenac from SCL and IOL materials for, at least, one week. Due to its high hydrophilicity (water contact angle≈0) and biocompatibility, it should avoid the use of further surface treatments to enhance the useŕs comfort. However, the barrier effect of this coating is specific for diclofenac, giving evidence to the need of optimizing the chemical composition of the layers in view of the desired drug. Copyright © 2016 Elsevier B.V. All rights reserved.
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21 CFR 524.1484a - Neomycin sulfate ophthalmic ointment.
2010-04-01
... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS...) Severe infections should be supplemented by systemic therapy. (5) Prolonged administration of the drug... bacteria or fungi appear during therapy, appropriate measures should be taken. (6) Federal law restricts...
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2011-10-14
...] Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and... Administration (FDA). The meeting will be open to the public. Name of Committees: Drug Safety and Risk Management... Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On December 1...
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In vitro testing of thiolated poly(aspartic acid) from ophthalmic formulation aspects.
Budai-Szű Cs, Mária; Horvát, Gabriella; Gyarmati, Benjámin; Szilágyi, Barnabás Áron; Szilágyi, András; Csihi, Tímea; Berkó, Szilvia; Szabó-Révész, Piroska; Mori, Michela; Sandri, Giuseppina; Bonferoni, Maria Cristina; Caramella, Carla; Csányi, Erzsébet
2016-08-01
Ocular drug delivery formulations must meet anatomical, biopharmaceutical, patient-driven and regulatory requirements. Mucoadhesive polymers can serve as a better alternative to currently available ophthalmic formulations by providing improved bioavailability. If all requirements are addressed, a polymeric formulation resembling the tear film of the eye might be the best solution. The optimum formulation must not have high osmotic activity, should provide appropriate surface tension, pH and refractive index, must be non-toxic and should be transparent and mucoadhesive. We would like to highlight the importance of in vitro polymer testing from a pharmaceutical aspect. We, therefore, carried out physical-chemical investigations to verify the suitability of certain systems for ophthalmic formulations. In this work, in situ gelling, mucoadhesive thiolated poly(aspartic acid)s were tested from ophthalmic formulation aspects. The results of preformulation measurements indicate that these polymers can be used as potential carriers in ophthalmic drug delivery.
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78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2013-12-17
...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... enter through Building 1. Contact Person: Kristina Toliver, Center for Drug Evaluation and Research... system atrophy, or pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic...
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Li, Jiawei; Zhao, Hainan; Okeke, Chukwunweike Ikechukwu; Li, Lin; Liu, Zhidong; Yin, Zhongpeng; Zhuang, Pengwei; Sun, Jingtong; Wu, Tao; Wang, Meng; Li, Nan; Pi, Jiaxin; Zhang, Qian; Zhang, Rui; Ma, Li; Pang, Xiaochen; Liu, Zhanbiao; Zhang, Li; Fan, Lili
2013-06-25
In recent years, many pharmaceutical scientists have focused on developing the in situ gel-forming systems to overcome the poor bioavailability and therapeutic response exhibited by conventional ophthalmic solutions due to rapid pre-corneal elimination of the drug. The present work was to compare the systemic absorptions of ophthalmic ofloxacin in situ gel with the conventional ofloxacin eye drop after topical instillation to rabbit eyes by HPLC-MS/MS method and also determine the relative contribution of the nasal and the conjunctival mucosae to systemic ofloxacin absorption following topical instillation. The systemic AUC, Cmax, Tmax and Ke for ophthalmic in situ gel and ophthalmic solution after ocular instillation were 202.63±118.85 and 202.25±57.74 ng mL(-1) h, 54.22±28.31 and 48.4±25.97 ng mL(-1), 1.08±0.20 and 1.25±0.88 h, 0.0576±0.0207 and 0.0388±0.0248, respectively. And the values for the ratios of the AUC of anterior chamber of rabbit eye to blood plasma, AUCac/AUCpl, for ofloxacin conventional eye drop and in situ gel were 0.25 and 0.52, respectively. Statistic results showed that there was no significant difference in systemic absorption between the test groups and the reference groups (P>0.05) as both formulations have an AUCsa/AUCpl of 0.35. Therefore, the ophthalmic in situ gel may not decrease the drugs systemic absorption when administered in an equivalent dose as ophthalmic solutions into the rabbit eyes. Copyright © 2013 Elsevier B.V. All rights reserved.
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21 CFR 524.390a - Chloramphenicol ophthalmic ointment.
2010-04-01
... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... treatment for 48 hours (2 days) after eye appears normal. Therapy for cats should not exceed 7 days... therapy should be considered. When infection may be cause of disease, especially in purulent or catarrhal...
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Horvát, Gabriella; Budai-Szűcs, Mária; Berkó, Szilvia; Szabóné-Révész, Piroska; Gyarmati, Benjámin; Szilágyi, Barnabas Áron; Szilágyi, András; Csányi Erzsébet
2015-01-01
The bioavailability of drugs used on mucosal surfaces can be increased by the use of mucoadhesive polymers. A new type of mucoadhesive polymers is the group of thiolated polymers with thiol group containing side chains. These polymers are able to form covalent bonds (disulphide linkages) with the mucin glycoproteins. For the formulation of an ocular drug delivery system (DDS) thiolated poly(aspartic acid) polymer (ThioPASP) was used. Our aim was to determine their biocompatibility, mucoadhesion and drug release property. According to the results it can be established that the thiolated poly(aspartic acid) polymers can be a potential vehicle of an ocular drug delivery system due to their biocompatibility, good mucoadhesive property and drug release profile. Thanks to their properties controlled drug delivery can be achieved and bioavailability of the ophthalmic formulation can be increased, while the usage frequency can be decreased.
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Zhu, Qiang; Cheng, Hongbo; Huo, Yingnan; Mao, Shirui
2018-06-10
In the present work the feasibility of using inner layer-embedded contact lenses (CLs) to achieve sustained release of highly water soluble drug, betaxolol hydrochloride (BH) on the ocular surface was investigated. Blend film of cellulose acetate and Eudragit S100 was selected as the inner layer, while silicone hydrogel was used as outer layer to construct inner layer-embedded contact lenses. Influence of polymer ratio in the blend film on in vitro drug release behavior in phosphate buffered solution or simulated tear fluid was studied and drug-polymer interaction, erosion and swelling of the blend film were characterized to better understand drug-release mechanism. Storage stability of the inner layer-embedded contact lenses in phosphate buffer solution was also conducted, with ignorable drug loss and negligible change in drug release pattern within 30 days. In vivo pharmacokinetic study in rabbits showed sustained drug release for over 240 h in tear fluid, indicating prolonged drug precorneal residence time. In conclusion, cellulose acetate/Eudragit S100 inner layer-embedded contact lenses are quite promising as controlled-release carrier of highly water soluble drug for ophthalmic delivery. Copyright © 2018 Elsevier B.V. All rights reserved.
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Directory of Open Access Journals (Sweden)
Chetan Chavan
2017-01-01
Full Text Available The major challenge associated with conventional eye-drop is the rapid drug loss due to precorneal defence barrier. In this context, controlled-release system of ciprofloxacin-conjugated chitosan (CS-Dextran sulphate (DS nanoparticles (NPs have been synthesized, to increase the bioavailability. The formulated drug delivery vehicle was evaluated for its therapeutic value in the simulated tear fluidat pH 7.4. Ophthalmic microbes were tested with this formulation, to confirm the drug efficacy; which showed conducive therapeutic values of both MIC and MBC. Ocular irritancy test was performed using HET-CAM test, which showed that the CS-DS system did not yield any vascular response, offering it to be a non-irritant to the ocular surface. The release studies showed monotonous controlled-release for duration of 21 h. A fine cross-linking between CS and DS has been demonstrated to form CS-DS NPs and their interaction with drug has been evaluated using conventional characterization tools.
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Clyde Schultz
2012-01-01
Gatifloxacin is a fourth generation fluroquinolone antibiotic that has been prescribed for systemic use. However, the drug which was developed by Kyorin (Japan) was linked to toxic reactions and death and was banned in the United States and Canada for use as an oral dosage form. It continues to be used as a topical application for ophthalmic conditions as the systemic toxicity seen when taking the drug orally has not been observed with ophthalmic use. The available data indicate that ocular u...
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Diclofenac ophthalmic solution is used to treat eye pain, redness, and swelling in patients who are recovering ... treat clouding of the lens in the eye). Diclofenac ophthalmic solution is also used to temporarily relieve ...
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76 FR 80949 - Request for Nominations for Voting Members on Public Advisory Panels or Committees
2011-12-27
.... Orthopedic and Rehabilitation Devices Panel. Jamie Waterhouse, Center for Devices Circulatory System Devices... Advisory Committee--Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain... ophthalmic clinical trials. Orthopaedic and 2 September 1, 2012. Rehabilitation Devices Panel of the Medical...
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Xu, Xiaoming; Al-Ghabeish, Manar; Rahman, Ziyaur; Krishnaiah, Yellela S R; Yerlikaya, Firat; Yang, Yang; Manda, Prashanth; Hunt, Robert L; Khan, Mansoor A
2015-09-30
Owing to its unique anatomical and physiological functions, ocular surface presents special challenges for both design and performance evaluation of the ophthalmic ointment drug products formulated with a variety of bases. The current investigation was carried out to understand and identify the appropriate in vitro methods suitable for quality and performance evaluation of ophthalmic ointment, and to study the effect of formulation and process variables on its critical quality attributes (CQA). The evaluated critical formulation variables include API initial size, drug percentage, and mineral oil percentage while the critical process parameters include mixing rate, temperature, time and cooling rate. The investigated quality and performance attributes include drug assay, content uniformity, API particle size in ointment, rheological characteristics, in vitro drug release and in vitro transcorneal drug permeation. Using design of experiments (DoE) as well as a novel principle component analysis approach, five of the quality and performance attributes (API particle size, storage modulus of ointment, high shear viscosity of ointment, in vitro drug release constant and in vitro transcorneal drug permeation rate constant) were found to be highly influenced by the formulation, in particular the strength of API, and to a lesser degree by processing variables. Correlating the ocular physiology with the physicochemical characteristics of acyclovir ophthalmic ointment suggested that in vitro quality metrics could be a valuable predictor of its in vivo performance. Published by Elsevier B.V.
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Directory of Open Access Journals (Sweden)
Clyde Schultz
2012-01-01
Full Text Available Gatifloxacin is a fourth generation fluroquinolone antibiotic that has been prescribed for systemic use. However, the drug which was developed by Kyorin (Japan was linked to toxic reactions and death and was banned in the United States and Canada for use as an oral dosage form. It continues to be used as a topical application for ophthalmic conditions as the systemic toxicity seen when taking the drug orally has not been observed with ophthalmic use. The available data indicate that ocular use of gatifloxacin is safe, and effective against a broad spectrum of bacteria, including intracellular bacteria and anaerobes.
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Jenke, Dennis; Egert, Thomas; Hendricker, Alan; Castner, James; Feinberg, Tom; Houston, Christopher; Hunt, Desmond G; Lynch, Michael; Nicholas, Kumudini; Norwood, Daniel L; Paskiet, Diane; Ruberto, Michael; Smith, Edward J; Holcomb, Frank; Markovic, Ingrid
2017-01-01
A simulating leaching (migration) study was performed on a model container-closure system relevant to parenteral and ophthalmic drug products. This container-closure system consisted of a linear low-density polyethylene bottle (primary container), a polypropylene cap and an elastomeric cap liner (closure), an adhesive label (labeling), and a foil overpouch (secondary container). The bottles were filled with simulating solvents (aqueous salt/acid mixture at pH 2.5, aqueous buffer at pH 9.5, and 1/1 v/v isopropanol/water), a label was affixed to the filled and capped bottles, the filled bottles were placed into the foil overpouch, and the filled and pouched units were stored either upright or inverted for up to 6 months at 40 °C. After storage, the leaching solutions were tested for leached substances using multiple complementary analytical techniques to address volatile, semi-volatile, and non-volatile organic and inorganic extractables as potential leachables.The leaching data generated supported several conclusions, including that (1) the extractables (leachables) profile revealed by a simulating leaching study can qualitatively be correlated with compositional information for materials of construction, (2) the chemical nature of both the extracting medium and the individual extractables (leachables) can markedly affect the resulting profile, and (3) while direct contact between a drug product and a system's material of construction may exacerbate the leaching of substances from that material by the drug product, direct contact is not a prerequisite for migration and leaching to occur. LAY ABSTRACT: The migration of container-related extractables from a model pharmaceutical container-closure system and into simulated drug product solutions was studied, focusing on circumstances relevant to parenteral and ophthalmic drug products. The model system was constructed specifically to address the migration of extractables from labels applied to the outside of the
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Kumagami, Takeshi; Wakiyama, Harumi; Kusano, Mao; Kajiyama, Ayano; Miura, Yoko; Uematsu, Masafumi; Yoneda, Ai; Kurihara, Junko; Suzuma, Kiyoshi; Kitaoka, Takashi
2014-05-01
The benzalkonium chloride (BAK) content of tafluprost ophthalmic solution (Tapros(®): tafluprost) has been reduced to balance corneal safety and preservative effectiveness (old formulation: 0.01%; new formulation: 0.001%). However, no reports have been published on its clinical effect. Therefore, we conducted a clinical research study to compare the safety of BAK-reduced tafluprost on the ocular surface with other prostaglandin ophthalmic solutions. This clinical study included 28 glaucoma patients (28 eyes) with a treatment history of latanoprost ophthalmic solution (Xalatan(®)) or travoprost ophthalmic solution (Travatan Z(®)), who presented with corneal epithelial disorders. The subjects were switched to BAK-reduced tafluprost, and its effect on the ocular surface was examined after 1 and 2 months of treatment [using fluorescein staining score, hyperemia, tear film breakup time, and intraocular pressure (IOP) lowering]. In all analyzed subjects (N=27), the fluorescein staining score was significantly improved after switching to BAK-reduced tafluprost (P<0.0001). Conversely, the IOP-lowering effect was not notably changed. The subjects switched from latanoprost (n=10) showed significant improvement in fluorescein staining score (P<0.05) as well as in IOP lowering (P<0.01). The subjects switched from travoprost (n=17) also showed significant improvement in fluorescein staining score (P<0.001), but without a significant change in IOP lowering. Tafluprost with reduced BAK has potential as a superior antiglaucoma drug, not only for its IOP-lowering effect, but also for its good corneal safety profile.
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21 CFR 524.1662b - Oxytetracycline hydrochloride, polymyxin B sulfate ophthalmic ointment.
2010-04-01
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Oxytetracycline hydrochloride, polymyxin B sulfate... DOSAGE FORM NEW ANIMAL DRUGS § 524.1662b Oxytetracycline hydrochloride, polymyxin B sulfate ophthalmic ointment. (a) Specifications. Each gram of the ointment contains oxytetracycline hydrochloride equivalent...
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Rajpal, Rajesh K; Ross, Bryan; Rajpal, Sachin D; Hoang, Khoa
2014-01-01
Rajesh K Rajpal, Bryan Ross, Sachin D Rajpal, Khoa HoangSee Clearly Vision Group, McLean, VA, USAAbstract: Ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used by clinicians to manage ocular inflammation and pain following cataract surgery. Over the past decade, the US Food and Drug Administration has approved multiple topical NSAIDs for these purposes, including several reformulated products. One of these medications, bromfenac ophthalmic solution, has a long and extens...
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2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...
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Efficacy of bromfenac sodium ophthalmic solution for treatment of dry eye disease.
Fujishima, Hiroshi; Fuseya, Miki; Ogata, Masarou; Murat, Dogru
2015-01-01
To evaluate the efficacy of bromfenac sodium ophthalmic solution (BF) in patients with dry eye disease (DED) inadequately controlled by monotherapy with artificial tears (ATs). An investigator-oriented trial with a single-arm, nonrandomized, open-label design. Twenty-six patients, who showed no symptomatic improvement of DED after 1 month of AT treatment, were enrolled. Bromfenac sodium ophthalmic solution was administered adjunctively with AT for 1 month. The BF treatment was then discontinued, and AT treatment alone was continued for 3 months. The signs and symptoms were evaluated at the beginning of BF treatment (Pre), at the end of the combined BF and AT treatment (BF1M), and at 1 and 3 months after discontinuation of BF treatment (Po1M and Po3M, respectively). The dryness scores at BF1M were significantly improved compared with Pre (P ophthalmic solution has improved the dryness of the eye and signs of DED through its anti-inflammatory effects. Nonsteroidal anti-inflammatory drugs were suitable as anti-inflammatory ophthalmic solutions for patients with DED.
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Ophthalmic Disorders in Adults with Down Syndrome
Directory of Open Access Journals (Sweden)
Sharon J. Krinsky-McHale
2012-01-01
Full Text Available A myriad of ophthalmic disorders is associated with the phenotype of Down syndrome including strabismus, cataracts, and refractive errors potentially resulting in significant visual impairment. Ophthalmic sequelae have been extensively studied in children and adolescents with Down syndrome but less often in older adults. In-depth review of medical records of older adults with Down syndrome indicated that ophthalmic disorders were common. Cataracts were the most frequent ophthalmic disorder reported, followed by refractive errors, strabismus, and presbyopia. Severity of intellectual disability was unrelated to the presence of ophthalmic disorders. Also, ophthalmic disorders were associated with lower vision-dependent functional and cognitive abilities, although not to the extent that was expected. The high prevalence of ophthalmic disorders highlights the need for periodic evaluations and individualized treatment plans for adults with Down syndrome, in general, but especially when concerns are identified.
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Pescina, Silvia; Macaluso, Claudio; Gioia, Gloria Antonia; Padula, Cristina; Santi, Patrizia; Nicoli, Sara
2017-09-01
The aim of the present paper was the development of semi-solid (hydrogels) and solid (film) ophthalmic formulations for the controlled release of two mydriatics: phenylephrine and tropicamide. The formulations - based on polyvinylalcohol and hyaluronic acid - were characterized, and release studies were performed with three different in vitro set-ups, i.e. Franz-type diffusion cell, vial method and inclined plane; for comparison, a solution and a commercial insert, both clinically used to induce mydriasis, were evaluated. Both gels and film allowed for a controlled release of drugs, appearing a useful alternative for mydriatics administration. However, the release kinetic was significantly influenced by the method used, highlighting the need for optimization and standardization of in vitro models for the evaluation of drug release from ophthalmic dosage forms.
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Topical ophthalmic NSAIDs: a discussion with focus on nepafenac ophthalmic suspension
Gaynes, Bruce I; Onyekwuluje, Anne
2008-01-01
Bruce I Gaynes1,2, Anne Onyekwuluje11Departments of Ophthalmology and 2Pharmacology, Rush College of Medicine, Chicago, Illinois, USAAbstract: The removal of diclofenac sodium ophthalmic solution as a viable pharmaceutical entity in September 1999 from the US market spurred considerable interest in the general safety and effectiveness of topical ophthalmic NSAIDs for treatment of anterior segment inflammation. In late 1999 the use of topical ocular NSAIDs declined in the US as a result of inc...
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21 CFR 886.3100 - Ophthalmic tantalum clip.
2010-04-01
... blood vessels in the eye. (b) Classification. Class II (special controls). The device is exempt from the...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently...
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75 FR 80059 - Advisory Committees; Tentative Schedule of Meetings for 2011
2010-12-21
.... Drugs Advisory Committee. Advisory Committee for Pharmaceutical March 2. Science and Clinical.... Science Board to the Food and Drug February 25, May 20, August 19, Administration. November 10. CENTER FOR... CENTER FOR TOXICOLOGICAL RESEARCH Science Advisory Board November 9-10. Dated: December 16, 2010. Jill...
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Financial return-on-investment of ophthalmic interventions: a new paradigm.
Brown, Melissa M; Brown, Gary C; Lieske, Heidi B; Lieske, P Alexander
2014-05-01
Although the patient value gain (improvement in quality-of-life and/or length-of-life) has been highlighted in Value-based Medicine cost-utility analyses, the financial value gain associated with healthcare interventions has received less emphasis. It is important for professional healthcare providers to realize their interventions often confer a large financial return-on-investment (ROI) to society. The societal costs associated with vitreoretinal and other ophthalmic interventions include: direct ophthalmic medical costs expended (hospital, physician, drug, diagnostic testing and so forth), direct medical costs saved (decreased costs for depression, injury, skilled nursing facility, nursing home and others), direct nonmedical costs saved (decreased costs for caregivers, transportation, residence costs, moving costs, and others), and indirect medical costs saved (improving employment incidence and wages). The financial ROI for direct ophthalmic medical costs expended for ranibizumab therapy for neovascular age-related macular degeneration is 450%, whereas that for cataract surgery is 4500% and for medical open-angle glaucoma therapy is 4000%. Many costs gained add to the Gross Domestic Product and increase the wealth of the nation. Many vitreoretinal and other ophthalmologic interventions confer considerable patient value, but also result in a large financial ROI to society. This financial ROI increases the wealth of the nation.
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76 FR 78931 - Advisory Committees; Tentative Schedule of Meetings for 2012
2011-12-20
..., April 30, May 1, August 16-17, November 1-2. Science Board to FDA January 6, May 2, October 3. CENTER... Date(s), if needed, to be Drugs Advisory Committee. determined. Advisory Committee for Pharmaceutical March 14. Science and Clinical Pharmacology. Psychopharmacologic Drugs Advisory Date(s), if needed, to...
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Communication: an ophthalmic practice issue.
Whitton, S J
1995-12-01
In the 1990's communication becomes an ophthalmic practice issue. The present ophthalmic climate of cost containment, downsizing, budget cuts, and lack of appreciation of contributions, results in a low staff morale. Recognition of the effects of job satisfaction and productivity led one group to seek solutions. A communication task force was formed to identify problems and the appropriate interventions.
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Gause, Samuel; Hsu, Kuan-Hui; Shafor, Chancellor; Dixon, Phillip; Powell, Kristin Conrad; Chauhan, Anuj
2016-07-01
Ophthalmic drug for the anterior chamber diseases are delivered into tears by either eye drops or by extended release devices placed in the eyes. The instilled drug exits the eye through various routes including tear drainage into the nose through the canaliculi and transport across various ocular membranes. Understanding the mechanisms relevant to each route can be useful in predicting the dependency of ocular bioavailability on various formulation parameters, such as drug concentration, salinity, viscosity, etc. Mathematical modeling has been developed for each of the routes and validated by comparison with experiments. The individual models can be combined into a system model to predict the fraction of the instilled drug that reaches the target. This review summarizes the individual models for the transport of drugs across the cornea and conjunctiva and the canaliculi tear drainage. It also summarizes the combined tear dynamics model that can predict the ocular bioavailability of drugs instilled as eye drops. The predictions from the individual models and the combined model are in good agreement with experimental data. Both experiments and models predict that the corneal bioavailability for drugs delivered through eye drops is less than 5% due to the small area of the cornea in comparison to the conjunctiva, and the rapid clearance of the instilled solution by tear drainage. A contact lens is a natural choice for delivering drugs to the cornea due to the placement of the contact in the immediate vicinity of the cornea. The drug released by the contact towards the cornea surface is trapped in the post lens tear film for extended duration of at least 30min allowing transport of a large portion into the cornea. The model predictions backed by in vivo animal and clinical data show that the bioavailability increases to about 50% with contact lenses. This realization has encouraged considerable research towards delivering ocular drugs by contact lenses. Commercial
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76 FR 52334 - Arthritis Advisory Committee; Notice of Postponement of Meeting
2011-08-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis Advisory Committee; Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is postponing the Arthritis Advisory...
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75 FR 55805 - Arthritis Advisory Committee; Notice of Meeting
2010-09-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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76 FR 42715 - Arthritis Advisory Committee; Notice of Meeting
2011-07-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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77 FR 13611 - Arthritis Advisory Committee; Notice of Meeting
2012-03-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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77 FR 1697 - Arthritis Advisory Committee; Notice of Meeting
2012-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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78 FR 33423 - Arthritis Advisory Committee; Notice of Meeting
2013-06-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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77 FR 70450 - Risk Communication Advisory Committee; Notice of Meeting
2012-11-26
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... 1. Contact Person: Lee L. Zwanziger, Risk Communication Staff, Food and Drug Administration, 10903...
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77 FR 62242 - Risk Communication Advisory Committee; Notice of Meeting
2012-10-12
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Person: Lee L. Zwanziger, Risk Communication Staff, Office of Planning, Food and Drug Administration...
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Application and study of conjunctival sac disinfectants in ophthalmic surgeries
Directory of Open Access Journals (Sweden)
Yan-Fei Luo
2016-01-01
Full Text Available Postoperative endophthalmitis is the most serious complications of ophthalmic surgeries. Conjunctival sac disinfection is currently recognized as an effectively important way to reduce the risk of endophthalmitis. At present, there are some disinfectants has been used in clinic or in the researches:mercury agent, gentamicin, povidone iodine and acid electrolytic water. All kinds of disinfectants play the role of disinfection by different ways. Povidone iodine is the most widely used conjunctival sac disinfectant. Mercurial and gentamicin have been rarely used because they pollute the environment, are easy to cause drug resistant bacteria, localized side reactions and so on. The acid electrolyte water is not used in clinic at present. With the popularization and development of the ophthalmic surgeries, the ophthalmologists have become more and more concerned about the postoperative eye comfort, the research and application of conjunctival sac disinfectant in the future will continue to be updated and developed.
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Sildenafil dilates ophthalmic artery in type 2 diabetic patients
Directory of Open Access Journals (Sweden)
Akeel AMH Zwain
2013-08-01
Full Text Available Background: Conflicting reports exist on the effect of sildenafil on ophthalmic artery blood flow; many visual disturbances due to vascular insult were reported with the use of sildenafil in diabetic patients like nonarteritic ischemic optic neuropathy. Objectives: The present work aimed to investigate whether sildenafil modulates ophthalmic artery vasoreactivity in patients with type 2 diabetes mellitus. Literature reports on this aspect are lacking. Methods: A total of 35 male subjects were enrolled in this study, 18 with type 2 diabetes mellitus matched with 17 normal individuals. Ophthalmic artery was insonated through a transorbital window using colored Doppler equipment with transcranial Doppler facility. Ophthalmic artery reactivity was assessed using breath holding/hyperventilation test, before and after giving 50 mg oral sildenafil. Results: It was found that in both normal subjects and diabetic patients, sildenafil increased baseline control of mean flow velocity of ophthalmic artery significantly (p 0.05 after sildenafil, in normal and diabetic groups. There was a significant increase of resistive index of ophthalmic artery flow in diabetic patients compared with that of normal subject (p < 0.05. Sildenafil decreased resistive index of ophthalmic artery flow significantly only in diabetic patients (p < 0.05. Conclusion: Sildenafil increased MFVopa, but had no significant effect on vasoreactivity of ophthalmic artery; sildenafil decreased resistive index only in type 2 diabetic patients.
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75 FR 4576 - Veterinary Medicine Advisory Committee; Notice of Meeting
2010-01-28
...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory... Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Pl...
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Transparency in Canadian public drug advisory committees.
Rosenberg-Yunger, Zahava R S; Bayoumi, Ahmed M
2014-11-01
Transparency in health care resource allocation decisions is a criterion of a fair process. We used qualitative methods to explore transparency across 11 Canadian drug advisory committees. We developed seven criteria to assess transparency (disclosure of members' names, disclosure of membership selection criteria, disclosure of conflict of interest guidelines and members' conflicts, public posting of decisions not to fund drugs, public posting of rationales for decisions, stakeholder input, and presence of an appeals mechanism) and two sub-criteria for when rationales were posted (direct website link and readability). We interviewed a purposeful sample of key informants who were conversant in English and a current or past member of either a committee or a stakeholder group. We analyzed data using a thematic approach. Interviewing continued until saturation was reached. We examined documents from 10 committees and conducted 27 interviews. The median number of criteria addressed by committees was 2 (range 0-6). Major interview themes included addressing: (1) accessibility issues, including stakeholders' degree of access to the decision making process and appeal mechanisms; (2) communication issues, including improving internal and external communication and public access to information; and (3) confidentiality issues, including the use of proprietary evidence. Most committees have some mechanisms to address transparency but none had a fully transparent process. The most important ways to improve transparency include creating formal appeal mechanisms, improving communication, and establishing consistent rules about the use of, and public access to, proprietary evidence. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
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Alternative methods of ophthalmic treatment in Russia.
Vader, L
1994-04-01
Russian ophthalmic nurses and physicians are using alternative methods of treatment to supplement traditional eye care. As acupuncture and iridology become more popular in the United States, ophthalmic nurses need to be more knowledgeable about these treatments and the implications for patients.
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76 FR 44017 - Risk Communication Advisory Committee; Notice of Meeting
2011-07-22
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... and former members of the Risk Communication Advisory Committee. FDA intends to make background...
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A new kind of monitor for ophthalmic operation
International Nuclear Information System (INIS)
Li, G; Wang, L L; Wang, Y; Lin, L; Jiang, W; Lu, Stephen C-Y; Besio, Walter G
2005-01-01
The integrity of the vision channel is often checked using VEP in order to avoiding damaging important tissue during an ophthalmic operation. But the measurement of before operations has strong side effects, it may damage the eyeball. We will introduce a new kind for monitoring ophthalmic operations in this paper. It uses visual electrical evoked potential to check the integrity of the vision access and it can monitor ophthalmic operations and avoid damaging any tissue, so it ensures the safety of the operation
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A new kind of monitor for ophthalmic operation
Energy Technology Data Exchange (ETDEWEB)
Li, G [College of Precision Instrument and Opto-Electronics Engineering, Tianjin University, Tianjin, 300072 (China); Wang, L L [College of Precision Instrument and Opto-Electronics Engineering, Tianjin University, Tianjin, 300072 (China); Wang, Y [College of Precision Instrument and Opto-Electronics Engineering, Tianjin University, Tianjin, 300072 (China); Lin, L [College of Precision Instrument and Opto-Electronics Engineering, Tianjin University, Tianjin, 300072 (China); Jiang, W [College of Precision Instrument and Opto-Electronics Engineering, Tianjin University, Tianjin, 300072 (China); Lu, Stephen C-Y [College of Precision Instrument and Opto-Electronics Engineering, Tianjin University, Tianjin, 300072 (China); Besio, Walter G [Biomedical Engineering Program, and Center for Biomedical Engineering and Rehabilitation Science Louisiana Tech. University, LA (United States)
2005-01-01
The integrity of the vision channel is often checked using VEP in order to avoiding damaging important tissue during an ophthalmic operation. But the measurement of before operations has strong side effects, it may damage the eyeball. We will introduce a new kind for monitoring ophthalmic operations in this paper. It uses visual electrical evoked potential to check the integrity of the vision access and it can monitor ophthalmic operations and avoid damaging any tissue, so it ensures the safety of the operation.
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Ultrasound-Enhanced Delivery of Antibiotics and Anti-Inflammatory Drugs into the Eye
Nabili, Marjan; Patel, Hetal; Mahesh, Sankaranarayana P.; Liu, Ji; Geist, Craig; Zderic, Vesna
2013-01-01
Delivery of sufficient amounts of therapeutic drugs into the eye is often a challenging task. In this study, ultrasound application (frequencies of 400 KHz to 1 MHz, intensities of 0.3–1.0 W/cm2 and exposure duration of 5 min) was investigated to overcome the barrier properties of cornea, which is a typical route for topical administration of ophthalmic drugs. Permeability of ophthalmic drugs, tobramycin and dexamethasone and sodium fluorescein, a drug-mimicking compound, was studied in ultra...
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75 FR 65641 - Risk Communication Advisory Committee; Amendment of Notice
2010-10-26
...] Risk Communication Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS... meeting of the Risk Communication Advisory Committee. This meeting was announced in the Federal Register... Communication Advisory Committee would be held on November 8 and 9, 2010. On page 57280, in the first column...
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Matsuo, Toshihiko; Gochi, Akira; Hirakawa, Tsuyoshi; Ito, Tadashi; Kohno, Yoshihisa
2010-10-01
General electronic medical records systems remain insufficient for ophthalmology outpatient clinics from the viewpoint of dealing with many ophthalmic examinations and images in a large number of patients. Filing systems for documents and images by Yahgee Document View (Yahgee, Inc.) were introduced on the platform of general electronic medical records system (Fujitsu, Inc.). Outpatients flow management system and electronic medical records system for ophthalmology were constructed. All images from ophthalmic appliances were transported to Yahgee Image by the MaxFile gateway system (P4 Medic, Inc.). The flow of outpatients going through examinations such as visual acuity testing were monitored by the list "Ophthalmology Outpatients List" by Yahgee Workflow in addition to the list "Patients Reception List" by Fujitsu. Patients' identification number was scanned with bar code readers attached to ophthalmic appliances. Dual monitors were placed in doctors' rooms to show Fujitsu Medical Records on the left-hand monitor and ophthalmic charts of Yahgee Document on the right-hand monitor. The data of manually-inputted visual acuity, automatically-exported autorefractometry and non-contact tonometry on a new template, MaxFile ED, were again automatically transported to designated boxes on ophthalmic charts of Yahgee Document. Images such as fundus photographs, fluorescein angiograms, optical coherence tomographic and ultrasound scans were viewed by Yahgee Image, and were copy-and-pasted to assigned boxes on the ophthalmic charts. Ordering such as appointments, drug prescription, fees and diagnoses input, central laboratory tests, surgical theater and ward room reservations were placed by functions of the Fujitsu electronic medical records system. The combination of the Fujitsu electronic medical records and Yahgee Document View systems enabled the University Hospital to examine the same number of outpatients as prior to the implementation of the computerized filing system.
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21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on the initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... technical advisory committee for human prescription drugs. The Commissioner's determinations on the agenda...
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determinants of general anaesthesia for ophthalmic surgery
African Journals Online (AJOL)
DR. CHARLES IMARENGIAYE
1999-08-01
Objectives: To study the pattern of anaesthesia for ophthalmic procedures in order to improve the scheduling of cases in the ophthalmic operating room. Methods: The surgical register of the operating room from. August 01, 1999 to July 31, 2004 was examined, to document the types of procedure, timing of surgery (elective ...
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76 FR 5380 - Advisory Committees; Filing of Closed Meeting Reports
2011-01-31
...] Advisory Committees; Filing of Closed Meeting Reports AGENCY: Food and Drug Administration, HHS. ACTION... Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA...), FDA has filed with the Library of Congress the annual reports for the following FDA advisory...
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78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting
2013-02-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...
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Clinical utility of 3% diquafosol ophthalmic solution in the treatment of dry eyes
Koh, Shizuka
2015-01-01
Diquafosol is a drug used for dry eye treatment with a novel mechanism of action. It stimulates the secretion of tear fluid and mucin on the ocular surface, thus enabling us to selectively treat the tear film layer, playing an important role in the establishment of the concept of “Tear Film Oriented Therapy (TFOT)”, an effective therapeutic approach to dry eye in Japan. The 3% diquafosol ophthalmic solution has been widely used for the treatment of dry eye in clinical practice, and it is currently available in Japan and South Korea. This review provides an overview of the clinical utility of 3% diquafosol ophthalmic solution, focusing on the results of clinical studies on various types of dry eye, including aqueous-deficient dry eye, short tear film breakup time-type dry eye, and post dry eye after laser in situ keratomileusis. It also introduces the additive effect of diquafosol on sodium hyaluronate monotherapy for dry eye, and the effect of 3% diquafosol ophthalmic solution for dry eye-related conditions. Additionally, it summarizes the ocular effects of diquafosol in healthy human eyes. Lastly, the importance of improving tear film stability in dry eye treatment, as well as general advances in dry eye treatments, are described. PMID:26028958
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Clinical utility of 3% diquafosol ophthalmic solution in the treatment of dry eyes.
Koh, Shizuka
2015-01-01
Diquafosol is a drug used for dry eye treatment with a novel mechanism of action. It stimulates the secretion of tear fluid and mucin on the ocular surface, thus enabling us to selectively treat the tear film layer, playing an important role in the establishment of the concept of "Tear Film Oriented Therapy (TFOT)", an effective therapeutic approach to dry eye in Japan. The 3% diquafosol ophthalmic solution has been widely used for the treatment of dry eye in clinical practice, and it is currently available in Japan and South Korea. This review provides an overview of the clinical utility of 3% diquafosol ophthalmic solution, focusing on the results of clinical studies on various types of dry eye, including aqueous-deficient dry eye, short tear film breakup time-type dry eye, and post dry eye after laser in situ keratomileusis. It also introduces the additive effect of diquafosol on sodium hyaluronate monotherapy for dry eye, and the effect of 3% diquafosol ophthalmic solution for dry eye-related conditions. Additionally, it summarizes the ocular effects of diquafosol in healthy human eyes. Lastly, the importance of improving tear film stability in dry eye treatment, as well as general advances in dry eye treatments, are described.
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2011-05-13
... marketing for reasons other than safety or effectiveness. ANDAs that refer to XIBROM (bromfenac ophthalmic... Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve...
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Mudgil, Meetali; Pawar, Pravin K
2013-01-01
The aim of the present investigation was to prepare a colloidal ophthalmic formulation to improve the residence time of moxifloxacin. Moxifloxacin-loaded poly(dl-lactide-co-glycolide) (PLGA) nanosuspensions were prepared by using the solvent evaporation technique. The nanosuspensions were characterised physically by using different techniques like particle size, zeta potential, FTIR, DSC, and XRD analysis. In vitro and ex vivo studies of nanosuspensions were carried out using a modified USP dissolution apparatus and all-glass Franz diffusion cells, respectively. The antibacterial activities of the nanosuspension and marketed formulations were performed against S. aureus and P. aeroginosa. The moxifloxacin-loaded PLGA nanosuspensions showed uniform particle size, ranging between 164-490 nm with negative zeta potential for all batches. The percentage entrapment efficiency of the drug-loaded nano-suspension was found to be between 84.09 to 92.05%. In vitro drug release studies suggest that all of the formulations showed extended drug release profiles and follow Korsemeyer-Peppas release kinetics. In vitro corneal permeability was found to be comparable with that of the marketed formulation across isolated goat cornea, indicating the suitability of the nanosuspension formulation in the ophthalmic delivery of moxifloxacin. The optimised nano-suspension was found to be more active against S. aureus and P. aeruginosa compared to the marketed eye drops.
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Patel, Nirav; Thakkar, Vaishali; Metalia, Viral; Baldaniya, Lalji; Gandhi, Tejal; Gohel, Mukesh
2016-09-01
The conventional liquid ophthalmic delivery systems exhibit short pre-corneal residence time and the relative impermeability to the cornea which leads to poor ocular bioavailability. The aim of this study was to apply quality by design (QbD) for development of dexamethasone sodium phosphate (DSP) and tobramycin sulfate (TS)-loaded thermoresponsive ophthalmic in situ gel containing Poloxamer 407 and hydroxyl propyl methyl cellulose (HPMC) K4M for prolonging the pre-corneal residence time, ocular bioavability and decreases the frequency of administration of dosage form. The material attributes and the critical quality attributes (CQA) of the in situ gel were identified. Central composite design (CCD) was adopted to optimize the formulation. The ophthalmic in situ forming gels were prepared by cold method. Materials attributes were the amount of Poloxamer 407 and HPMC and CQA identified were Gel strength, mucoadhesive index, gelation temperature and % of drug release of both drug. Optimized batch (F*) containing 16.75% poloxamer 407 and 0.54% HPMC K4M were exhibited all results in acceptable limits. Compared with the marketed formulation, optimized in situ gel showed delayed Tmax, improved Cmax and AUC in rabbit aqueous humor, suggesting the sustained drug release and better corneal penetration and absorption. According to the study, it could be concluded that DSP and TS would be successfully formulated as in situ gelling mucoadhesive system for the treatment of steroid responsive eye infections with the properties of sustained drug release, prolonged ocular retention and improved corneal penetration.
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Ophthalmic masquerades of the atherosclerotic carotids
Directory of Open Access Journals (Sweden)
Anupriya Arthur
2014-01-01
Full Text Available Patients with carotid atherosclerosis can present with ophthalmic symptoms. These symptoms and signs can be due to retinal emboli, hypoperfusion of the retina and choroid, opening up of collateral channels, or chronic hypoperfusion of the globe (ocular ischemic syndrome. These pathological mechanisms can produce many interesting signs and a careful history can bring out important past symptoms pointing toward the carotid as the source of the patient′s presenting symptom. Such patients are at high risk for an ischemic stroke, especially in the subsequent few days following their first acute symptom. It is important for clinicians to be familiar with these ophthalmic symptoms and signs caused by carotid atherosclerosis for making an early diagnosis and to take appropriate measures to prevent a stroke. This review elaborates the clinical features, importance, and implications of various ophthalmic symptoms and signs resulting from atherosclerotic carotid artery disease.
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Liu, Bing; Ding, Li; Xu, Xiaowen; Lin, Hongda; Sun, Chenglong; You, Linjun
2015-12-01
Lidocaine hydrochloride ophthalmic gel is a novel ophthalmic preparation for topical ocular anesthesia. The study is aimed at evaluating the ocular and systemic pharmacokinetics of lidocaine hydrochloride 3.5 % ophthalmic gel in rabbits after ocular topical administration. Thirty-six rabbits were randomly placed in 12 groups (3 rabbits per group). The rabbits were quickly killed according to their groups at 0 (predose), 0.0833, 0.167, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, and 8 h postdose and then the ocular tissue and plasma samples were collected. All the samples were analyzed by a validated LC-MS/MS method. The test result showed that the maximum concentration (C max) of lidocaine in different ocular tissues and plasma were all achieved within 20 min after drug administration, and the data of C max were (2,987 ± 1814) μg/g, (44.67 ± 12.91) μg/g, (26.26 ± 7.19) μg/g, (11,046 ± 2,734) ng/mL, and (160.3 ± 61.0) ng/mL for tear fluid, cornea, conjunctiva, aqueous humor, and plasma, respectively. The data of the elimination half-life in these tissues were 1.5, 3.2, 3.5, 1.9, and 1.7 h for tear fluid, cornea, conjunctiva, aqueous humor, and plasma, respectively. The intraocular lidocaine levels were significantly higher than that in plasma, and the elimination half-life of lidocaine in cornea, conjunctiva, and aqueous humor was relatively longer than that in tear fluid and plasma. The high intraocular penetration, low systemic exposure, and long duration in the ocular tissues suggested lidocaine hydrochloride 3.5 % ophthalmic gel as an effective local anesthetic for ocular anesthesia during ophthalmic procedures.
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Griggs, Angela N; Yaw, Taylor J; Haynes, Joseph S; Ben-Shlomo, Gil; Tofflemire, Kyle L; Allbaugh, Rachel A
2017-03-01
To determine if topical ophthalmic diclofenac sodium 0.1% solution alters renal parameters in the domestic chicken, and to determine if the drug is detectable in plasma after topical ophthalmic administration. Thirty healthy domestic chickens. Over 7 days, six birds were treated unilaterally with one drop of artificial tear solution (group 1), 12 birds were treated unilaterally (group 2) and 12 bilaterally (group 3) with diclofenac sodium 0.1% ophthalmic solution. Treatments were provided every 12 h in all groups. Pre- and post-treatment plasma samples from all birds were evaluated for changes in albumin, total protein, and uric acid. Post-treatment samples of all birds, collected 15 min post-administration, were analyzed by high-performance liquid chromatography with mass spectrometry for diclofenac sodium detection. A randomly selected renal sample from each group was submitted for histopathologic review. Changes in pre- and post-treatment plasma albumin were significant (P Ophthalmic diclofenac sodium 0.1% administered topically every 12 h in one or both eyes for 7 days is detectable in systemic circulation in the domestic chicken, but does not cause overt significant changes in plasma uric acid or total protein. © 2016 American College of Veterinary Ophthalmologists.
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75 FR 66381 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2010-10-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...
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76 FR 49774 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2011-08-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...
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76 FR 64951 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2011-10-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...
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78 FR 15726 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2013-03-12
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of...
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Treatment of neuro-ophthalmic sarcoidosis.
Frohman, Larry P
2015-03-01
Because of the rarity of neuro-ophthalmic sarcoidosis, there are no therapeutic guidelines based on evidence-based medicine for this disorder. Review of literature combined with personal experience. Corticosteroids are the preferred initial therapy for neuro-ophthalmic sarcoidosis. If patients cannot tolerate the requisite dose of corticosteroid needed to control their disease, or if corticosteroids fail to adequately control the disease process, the choices of a second agent are based on the consideration of rapidity of clinical response and the safety profile. Although methotrexate and mycophenolate mofetil are the medications that are often selected after corticosteroid failure, more rapidly acting agents that have been used are infliximab and intravenous cyclophosphamide.
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Audit of Referrals to an Ophthalmic Outpatient Clinic of a Tertiary ...
African Journals Online (AJOL)
Objectives: To determine the referral pattern and assess the quality and accuracy of referral letters to the ophthalmic outpatient clinic of University of Nigeria Teaching Hospital, Enugu. Methods: This study is a prospective cross-sectional survey of all new ophthalmic referrals to the ophthalmic outpatient clinic at University of ...
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78 FR 32403 - Arthritis Advisory Committee; Notice of Meeting
2013-05-30
...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee..., the committee will discuss the Assessment of SpondyloArthritis international Society classification...
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Douet, Jean-Yves; Michel, Julien; Regnier, Alain
2013-10-01
To assess the anesthetic efficacy and local tolerance of topically applied 0.4% oxybuprocaine ophthalmic solution to in dogs and compare its effects with those of 1% tetracaine solution. 34 ophthalmically normal Beagles. Dogs were assigned to 2 groups, and baseline corneal touch threshold (CTT) was measured bilaterally with a Cochet-Bonnet aesthesiometer. Dogs of group 1 (n = 22) received a single drop of 0.4% oxybuprocaine ophthalmic solution in one eye and saline (0.9% NaCl) solution (control treatment) in the contralateral eye. Dogs of group 2 (n = 12) received a single drop of 0.4% oxybuprocaine ophthalmic solution in one eye and 1% tetracaine ophthalmic solution in the contralateral eye. The CTT of each eye was measured 1 and 5 minutes after topical application and then at 5-minute intervals until 75 minutes after topical application. CTT changes over time differed significantly between oxybuprocaine-treated and control eyes. After instillation of oxybuprocaine, maximal corneal anesthesia (CTT = 0) was achieved within 1 minute, and CTT was significantly decreased from 1 to 45 minutes, compared with the baseline value. No significant difference in onset, depth, and duration of corneal anesthesia was found between oxybuprocaine-treated and tetracaine-treated eyes. Conjunctival hyperemia and chemosis were detected more frequently in tetracaine-treated eyes than in oxybuprocaine-treated eyes. Topical application of oxybuprocaine and tetracaine similarly reduced corneal sensitivity in dogs, but oxybuprocaine was less irritating to the conjunctiva than was tetracaine.
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Diquafosol ophthalmic solution 3 %: a review of its use in dry eye.
Keating, Gillian M
2015-05-01
Diquafosol ophthalmic solution 3 % (Diquas(®)) is a P2Y2 receptor agonist that promotes tear fluid and mucin secretion and is currently approved in Japan and South Korea for the treatment of dry eye. In randomized, double-blind, multicentre trials in patients with dry eye, significantly greater improvements in fluorescein and rose bengal staining scores were seen with diquafosol ophthalmic solution 3 % than with placebo, and diquafosol ophthalmic solution 3 % was noninferior to sodium hyaluronate ophthalmic solution 0.1 % in terms of the improvement in the fluorescein staining score and more effective than sodium hyaluronate ophthalmic solution 0.1 % in terms of the improvement in the rose bengal staining score. The efficacy of diquafosol ophthalmic solution 3 % in the treatment of dry eye was maintained in the longer term, with improvements also seen in subjective dry eye symptoms, and was also shown in a real-world setting. Diquafosol ophthalmic solution 3 % also demonstrated efficacy in various specific dry eye disorders, including aqueous-deficient dry eye, short tear film break-up time dry eye, obstructive meibomian gland dysfunction, dry eye following laser in situ keratomileusis surgery and dry eye following cataract surgery, as well as in contact lens wearers and visual display terminal users. Diquafosol ophthalmic solution 3 % was generally well tolerated in patients with dry eye, with eye irritation the most commonly reported adverse event. In conclusion, diquafosol ophthalmic solution 3 % is a useful option for the treatment of dry eye.
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75 FR 5335 - Risk Communication Advisory Committee; Notice of Meeting
2010-02-02
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... previously issued communications, emphasizing communications challenges. Examples, selected for illustrative...
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Rate of bacterial eradication by ophthalmic solutions of fourth-generation fluoroquinolones.
Callegan, Michelle C; Novosad, Billy D; Ramadan, Raniyah T; Wiskur, Brandt; Moyer, Andrea L
2009-04-01
Antibacterial activity of ophthalmic fourth-generation fluoroquinolones has traditionally been evaluated by comparing only their active ingredients, gatifloxacin and moxifloxacin. However, ophthalmic formulations of fourth-generation fluoroquinolones differ in terms of the inclusion of preservatives. While gatifloxacin ophthalmic solution 0.3% (Zymar; Allergan, Inc., Irvine, CA, USA) contains 0.005% benzalkonium chloride (BAK), moxifloxacin ophthalmic solution 0.5% (Vigamox; Alcon Laboratories, Inc., Fort Worth, TX, USA) is preservative-free. Recent studies have demonstrated that the presence of BAK dramatically affects the antibacterial activity of the ophthalmic formulation of gatifloxacin. This study was designed to compare the kill rates of ophthalmic solutions of fourth-generation fluoroquinolones against isolates of common ocular bacterial pathogens. Approximately 5.6 log(10) colony-forming units (CFU)/mL of Haemophilus influenzae (n=1), Streptococcus pneumoniae (n=1), Staphylococcus aureus (n=2), methicillin-resistant Staphylococcus aureus (MRSA) (n=4), methicillinresistant Staphylococcus epidermidis (MRSE) (n=4), and fluoroquinolone-resistant S. epidermidis (n=1) were incubated with ophthalmic solutions of either gatifloxacin or moxifloxacin. Viable bacteria were quantified at specific time points up to 60 minutes. Gatifloxacin 0.3% completely eradicated H. influenzae and Strep. pneumoniae in 5 minutes, one of two S. aureus isolates in 15 minutes, and the other S. aureus isolate in 60 minutes. Gatifloxacin 0.3% completely killed all MRSA, MRSE, and fluoroquinolone-resistant S. epidermidis isolates in 15 minutes. Moxifloxacin 0.5% completely eradicated Strep. pneumoniae and one of four MRSA isolates in 60 minutes. All other isolates incubated with moxifloxacin 0.5% retained viable bacteria ranging from 1.8 to 4.4 log(10) CFU/mL. The ophthalmic solution of gatifloxacin 0.3% eradicated bacteria that frequently cause postoperative ocular infections
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77 FR 14529 - Arthritis Advisory Committee; Notice of Meeting
2012-03-12
...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee... the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had...
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76 FR 58519 - Risk Communication Advisory Committee; Notice of Meeting
2011-09-21
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... discuss implications, for strategic communication, of recent theoretical developments on information use...
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Contact lenses as drug controlled release systems: a narrative review
Directory of Open Access Journals (Sweden)
Helena Prior Filipe
2016-06-01
Full Text Available ABSTRACT Topically applied therapy is the most common way to treat ocular diseases, however given the anatomical and physiological constraints of the eye, frequent dosing is required with possible repercussions in terms of patient compliance. Beyond refractive error correction, contact lenses (CLs have, in the last few decades emerged as a potential ophthalmic drug controlled release system (DCRS. Extensive research is underway to understand how to best modify CLs to increase residence time and bioavailability of drugs within therapeutic levels on the ocular surface.These devices may simultaneously correct ametropia and have a role in managing ophthalmic disorders that can hinder CL wear such as dry eye, glaucoma, ocular allergy and cornea infection and injury. In this narrative review the authors explain how the ocular surface structures determine drug diffusion in the eye and summarize the strategies to enhance drug residence time and bioavailability. They synthesize findings and clinical applications of drug soaked CLs as DCRS combined with delivery diffusion barriers, incorporation of functional monomers, ion related controlled release, molecular imprinting, nanoparticles and layering. The authors draw conclusions about the impact of these novel ophthalmic agents delivery systems in improving drug transport in the target tissue and patient compliance, in reducing systemic absorption and undesired side effects, and discuss future perspectives.
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76 FR 29767 - Arthritis Advisory Committee; Notice of Meeting
2011-05-23
...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee... indication: ``ILARIS is indicated for the treatment of gouty arthritis attacks. ILARIS has also been shown to...
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Development and Effects of FTY720 Ophthalmic Solution on Corneal Allograft Survival.
Liu, Zhaochuan; Lin, Haotian; Huang, Chulong; Chen, Wan; Xiang, Wu; Geng, Yu; Chen, Weirong
2015-11-12
Fingolimod (FTY720), a novel class of sphingosine 1-phosphate receptor modulators, has received special interest among ophthalmologists, particularly given that oral administration of FTY720 has proven to effectively treat corneal graft rejection in animal models. However, no studies have examined the performance of FTY720 as an ophthalmic solution in reducing corneal rejection in high-risk corneal rejection models, and the stability and ocular irritation profile of FTY720 ophthalmic solution are also unknown. Thus, we developed 0.1%, 0.2% and 0.5% FTY720 ophthalmic solutions and evaluated their chemical stabilities under various storage conditions with high- performance liquid chromatography. To investigate the ocular irritancy of the FTY720 ophthalmic solution, New Zealand albino rabbits were subjected to the Draize test. Furthermore, classic, well-established rat allogenic penetrating keratoplasty models were used to investigate the anti-rejection efficacy of the tested FTY720 ophthalmic solutions. We found that the non-irritating 0.5% FTY720 ophthalmic solution could prolong corneal allograft survival in rats with significant efficacy for about one month. Furthermore, no significant concentration changes occurred in any of the types of FTY720 ophthalmic solutions within three months. These results revealed crucial profiles of FTY720 ophthalmic solutions and warrant further investigation and optimization of FTY720 in the anti-rejection therapy after keratoplasty.
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75 FR 57279 - Risk Communication Advisory Committee; Notice of Meeting
2010-09-20
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Committee will hear and discuss developments in FDA's ongoing communications programs, such as FDA's...
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Lifitegrast Ophthalmic Solution 5%: A Review in Dry Eye Disease.
Keating, Gillian M
2017-02-01
Lifitegrast is a novel small molecule integrin antagonist that blocks the binding of intercellular adhesion molecule 1 (ICAM-1) to lymphocyte function-associated antigen 1 (LFA-1). Lifitegrast ophthalmic solution 5% (Xiidra™) was recently approved in the USA for the treatment of dry eye disease. The efficacy of lifitegrast ophthalmic solution 5% was compared with vehicle in a 12-week phase 2 study and three 12-week phase 3 studies (OPUS-1, OPUS-2 and OPUS-3) in patients with dry eye disease. Taken as a whole, results of these trials support the treatment effect of lifitegrast ophthalmic solution 5% in improving a symptom of dry eye disease (i.e. the change from baseline to day 84 in the eye dryness visual analogue scale score) and a sign of dry eye disease (i.e. the change from baseline to day 84 in the inferior corneal fluorescein staining score). Lifitegrast ophthalmic solution 5% was generally well tolerated. In conclusion, lifitegrast ophthalmic solution 5% provides a new option for the treatment of dry eye disease.
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Grey, Katherine R; Warshaw, Erin M
Allergic contact dermatitis is an important cause of periorbital dermatitis. Topical ophthalmic agents are relevant sensitizers. Contact dermatitis to ophthalmic medications can be challenging to diagnose and manage given the numerous possible offending agents, including both active and inactive ingredients. Furthermore, a substantial body of literature reports false-negative patch test results to ophthalmic agents. Subsequently, numerous alternative testing methods have been described. This review outlines the periorbital manifestations, causative agents, and alternative testing methods of allergic contact dermatitis to ophthalmic medications.
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Readability assessment of online ophthalmic patient information.
Edmunds, Matthew R; Barry, Robert J; Denniston, Alastair K
2013-12-01
Patients increasingly use the Internet to access information related to their disease, but poor health literacy is known to impact negatively on medical outcomes. Multiple agencies have recommended that patient-oriented literature be written at a fourth- to sixth-grade (9-12 years of age) reading level to assist understanding. The readability of online patient-oriented materials related to ophthalmic diagnoses is not yet known. To assess the readability of online literature specifically for a range of ophthalmic conditions. Body text of the top 10 patient-oriented websites for 16 different ophthalmic diagnoses, covering the full range of ophthalmic subspecialties, was analyzed for readability, source (United Kingdom vs non-United Kingdom, not for profit vs commercial), and appropriateness for sight-impaired readers. Four validated readability formulas were used: Flesch Reading Ease Score (FRES), Flesch-Kincaid Grade Level (FKGL), Simple Measure of Gobbledygook (SMOG), and Gunning Fog Index (GFOG). Data were compared with the Mann-Whitney test (for 2 groups) and Kruskal-Wallis test (for more than 2 groups) and correlation was assessed by the Spearman r. None of the 160 webpages had readability scores within published guidelines, with 83% assessed as being of "difficult" readability. Not-for-profit webpages were of significantly greater length than commercial webpages (P = .02) and UK-based webpages had slightly superior readability scores compared with those of non-UK webpages (P = .004 to P readability formula used). Of all webpages evaluated, only 34% included facility to adjust text size to assist visually impaired readers. To our knowledge, this is the first study to assess readability of patient-focused webpages specifically for a range of ophthalmic diagnoses. In keeping with previous studies in other medical conditions, we determined that readability scores were inferior to those recommended, irrespective of the measure used. Although readability is only one
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Bilateral IgG4-related ophthalmic disease: a strong indication for systemic imaging.
Wu, Albert; Andrew, Nicholas H; McNab, Alan A; Selva, Dinesh
2016-10-01
To investigate whether bilateral or unilateral IgG4-related ophthalmic disease (IgG4-ROD) is associated with extra-ophthalmic IgG4-related disease (IgG4-RD). Twin-centre retrospective observational case series of biopsy-confirmed IgG4-ROD. Clinical and radiology data were reviewed for laterality of IgG4-ROD and presence of extra-ophthalmic disease. The literature was reviewed for case series of IgG4-ROD. 40 IgG4-ROD cases were identified, with median follow-up of 36 months. At diagnosis of IgG4-ROD, all cases were screened for extra-ophthalmic disease with physical examination and blood testing. Systemic imaging was performed in 20 (50%) cases due to clinical suspicion of extra-ophthalmic disease. Of the 21 unilateral IgG4-ROD cases, 3 (14%) had extra-ophthalmic involvement. Of the 19 bilateral cases, 15 (79%) had extra-ophthalmic involvement. Extra-ophthalmic involvement was strongly associated with bilateral IgG4-ROD (pIgG4-ROD is strongly associated with extra-ophthalmic IgG4-RD. We recommend that imaging of the neck, chest, abdomen and pelvis be performed for all bilateral cases. Systemic imaging should also be considered in unilateral cases as a significant proportion of these patients will also have extra-ophthalmic disease. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
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76 FR 16427 - Risk Communication Advisory Committee; Notice of Meeting
2011-03-23
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... discuss developments in FDA's ongoing communications programs. The discussion will focus on the use of...
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75 FR 20608 - Risk Communication Advisory Committee; Notice of Meeting
2010-04-20
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... relevant to improving risk communication at FDA, and discuss applications or gaps for strategic planning of...
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77 FR 65693 - Cellular, Tissue and Gene Therapies Advisory Committee; Amendment of Notice
2012-10-30
...] Cellular, Tissue and Gene Therapies Advisory Committee; Amendment of Notice AGENCY: Food and Drug... notice of a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. This meeting was... announced that a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee would be held on...
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Ayaki, Masahiko; Iwasawa, Atsuo; Yaguchi, Shigeo; Koide, Ryohei
2010-12-01
In the present study, we evaluated the cytotoxicity of anti-allergic ophthalmic solutions in cultured corneal and conjunctival cells, namely SIRC (rabbit corneal epithelium), BCE C/D-1b (bovine corneal epithelial cells), RC-1 (rabbit corneal epithelium), and Chang (human conjunctival cells). The viability of cell cultures was determined following the exposure of cells to 12 commercially available anti-allergic ophthalmic solutions for varying exposure times and at various dilutions using the MTT and neutral red assays. The cell viability score (CVS) was used to compare the toxicity of different drugs. Based on CVS data, the order of cell viability after exposure to the drugs was Zepelin ≥ Tramelas PF ≥ Cumorol PF ≥ Ketotifen PF ≥ Eyevinal = Fumarton ≥ Cumorol > Intal ≥ Rizaben ≥ Tramelas ≥ Patanol Livostin. In conclusion, cell viability was mostly affected by the concentration of benzalkonium chloride rather than the active component and/or the anti-allergic action of the drug. The CVS was useful in comparing the toxicity of different drugs.
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Clinical utility of 3% diquafosol ophthalmic solution in the treatment of dry eyes
Directory of Open Access Journals (Sweden)
Koh S
2015-05-01
Full Text Available Shizuka Koh Department of Ophthalmology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan Abstract: Diquafosol is a drug used for dry eye treatment with a novel mechanism of action. It stimulates the secretion of tear fluid and mucin on the ocular surface, thus enabling us to selectively treat the tear film layer, playing an important role in the establishment of the concept of “Tear Film Oriented Therapy (TFOT”, an effective therapeutic approach to dry eye in Japan. The 3% diquafosol ophthalmic solution has been widely used for the treatment of dry eye in clinical practice, and it is currently available in Japan and South Korea. This review provides an overview of the clinical utility of 3% diquafosol ophthalmic solution, focusing on the results of clinical studies on various types of dry eye, including aqueous-deficient dry eye, short tear film breakup time-type dry eye, and post dry eye after laser in situ keratomileusis. It also introduces the additive effect of diquafosol on sodium hyaluronate monotherapy for dry eye, and the effect of 3% diquafosol ophthalmic solution for dry eye-related conditions. Additionally, it summarizes the ocular effects of diquafosol in healthy human eyes. Lastly, the importance of improving tear film stability in dry eye treatment, as well as general advances in dry eye treatments, are described. Keywords: diquafosol, dry eye, mucin secretion, fluid secretion, ocular surface, vision
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Medical physics aspects of ophthalmic brachytherapy
International Nuclear Information System (INIS)
Sharma, S.D.; Shanta, A.; Palani Selvam, T.; Tripathi, U.B.; Bhatt, B.C.
2004-11-01
Intraocular melanoma is the most common primary malignancy of the eye. Radiation therapy using ophthalmic plaque has proved successful in the management of various ocular lesions. Although a few centres were using 90 Sr/ 90 Y plaques for shallow turtlours some years ago, eye plaque therapy was not a common practice in India. A revived interest in the use of eye plaque therapy and very high cost of imported sources has led to the development and production of 125 I seed sources by the Radiopharmaceuticals Division, BARC. This report presents a brief description on the clinical, dosimetry and radiation safety aspects of 90 Sr/ 90 Y and 106 Ru/ 106 Rh beta ray and 125 I gamma ray eye plaque applicators. This report has been divided in five Sections. Section I presents general introduction of ophthalmic brachytherapy including the structure of a human eye, types of ophthalmic plaques and characteristics of radioisotopes commonly used in such applications. A brief review of sources, applicators and dosimetry of 90 Sr/ 90 Y and 106 Ru/ 106 Rh beta and 125 I gamma ophthalmic plaques are given in Section II and Section III, respectively. Section IV contains the single seed dosimetry data of BARC OcuProsta 125 I seed as well as dosimetry data of typical eye plaques loaded with BARC OcuProsta 125 I seed. Quality assurance and radiation safety aspects of these eye applicators are described in Section V. A proforma of the application required to be filled in by the user institution for obtaining regulatory consent to start eye plaque therapy has also been appended to this report. (author)
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21 CFR 14.95 - Compensation of advisory committee members.
2010-04-01
... employees, but are reimbursed by the Food and Drug Administration for travel expenses. (b) Notwithstanding... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Compensation of advisory committee members. 14.95 Section 14.95 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...
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75 FR 52605 - Veterinary Medicine Advisory Committee; Notice of Meeting
2010-08-26
...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory..., Rockville, MD 20852, 301-468-1100. Contact Person: Aleta Sindelar, Center for Veterinary Medicine (HFV-3...
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2013-05-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...
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76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
2011-08-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...
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Kim, Yong-Kyu; Jung, Cheolkyu; Woo, Se Joon; Park, Kyu Hyung
2015-12-01
Cosmetic facial filler-related ophthalmic artery occlusion is rare but is a devastating complication, while the exact pathophysiology is still elusive. Cerebral angiography provides more detailed information on blood flow of ophthalmic artery as well as surrounding orbital area which cannot be covered by fundus fluorescein angiography. This study aimed to evaluate cerebral angiographic features of cosmetic facial filler-related ophthalmic artery occlusion patients. We retrospectively reviewed cerebral angiography of 7 patients (4 hyaluronic acid [HA] and 3 autologous fat-injected cases) showing ophthalmic artery and its branches occlusion after cosmetic facial filler injections, and underwent intra-arterial thrombolysis. On selective ophthalmic artery angiograms, all fat-injected patients showed a large filling defect on the proximal ophthalmic artery, whereas the HA-injected patients showed occlusion of the distal branches of the ophthalmic artery. Three HA-injected patients revealed diminished distal runoff of the internal maxillary and facial arteries, which clinically corresponded with skin necrosis. However, all fat-injected patients and one HA-injected patient who were immediately treated with subcutaneous hyaluronidase injection showed preserved distal runoff of the internal maxillary and facial arteries and mild skin problems. The size difference between injected materials seems to be associated with different angiographic findings. Autologous fat is more prone to obstruct proximal part of ophthalmic artery, whereas HA obstructs distal branches. In addition, hydrophilic and volume-expansion property of HA might exacerbate blood flow on injected area, which is also related to skin necrosis. Intra-arterial thrombolysis has a limited role in reconstituting blood flow or regaining vision in cosmetic facial filler-associated ophthalmic artery occlusions.
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78 FR 63224 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
2013-10-23
... treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare congenital... Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate...Committees/Calendar/default.htm . Scroll down to the appropriate advisory committee meeting link. Procedure...
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ANAESTHESIA FOR OPHTHALMIC SURGICAL PROCEDURES
African Journals Online (AJOL)
Objective: To review factors influencing the choice of anaesthesia for ophthalmic surgical procedures. ... as risk associated with general anaesthesia (8) they are more .... Wilson ME, Pandey SK, Thakur J. Paediatric cataract blindness in the ...
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Ophthalmic artery color Doppler ultrasonography in mild-to-moderate preeclampsia
International Nuclear Information System (INIS)
Ayaz, Tunahan; Akansel, Gur.; Hayirlioglu, Alper; Arslan, Arzu; Suer, Necdet; Kuru, Ihsan
2003-01-01
Objective: To evaluate the hemodynamic changes in mild-moderate preeclampsia using ophthalmic artery Doppler ultrasonography technique. Methods: Ophthalmic artery pulsatility and resistivity indices were calculated in 30 mild-moderate preeclamptic women and 30 normotensive gravid women of matched gestational age. Student's t-test was performed to test the significance of difference. Results: Both indices of peripheral resistance were found to be significantly lower in the ophthalmic arteries of mild-moderately preeclamptic women than those measured in normotensive gravid women at similar stage of pregnancy. In a small number patients whose disease progressed to severe preeclampsia, both indices increased. Conclusion: In patients with mild-moderate preeclampsia, ophthalmic artery color Doppler ultrasonography detects hemodynamic changes that are not present in normotensive gravid women. Reversal of Doppler patterns in a small number of patients with progressive disease supports the hypotheses suggesting the presence of early vasodilation and late vasospasm in the etiology of preeclampsia
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Polymyxin B and Trimethoprim Ophthalmic
Polymyxin B and trimethoprim ophthalmic combination is used to treat bacterial infections of the eye including conjunctivitis (pinkeye; infection ... inside and outer parts of the eyelid). Polymyxin B and trimethoprim are in a class of medications ...
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Ophthalmic regional blocks: management, challenges, and solutions
Directory of Open Access Journals (Sweden)
Palte HD
2015-08-01
Full Text Available Howard D Palte Department of Anesthesiology, Perioperative Medicine and Pain Management, Miller School of Medicine, University of Miami, Miami, FL, USA Abstract: In the past decade ophthalmic anesthesia has witnessed a major transformation. The sun has set on the landscape of ophthalmic procedures performed under general anesthesia at in-hospital settings. In its place a new dawn has ushered in the panorama of eye surgeries conducted under regional and topical anesthesia at specialty eye care centers. The impact of the burgeoning geriatric population is that an increasing number of elderly patients will present for eye surgery. In order to accommodate increased patient volumes and simultaneously satisfy administrative initiatives directed at economic frugality, administrators will seek assistance from anesthesia providers in adopting measures that enhance operating room efficiency. The performance of eye blocks in a holding suite meets many of these objectives. Unfortunately, most practicing anesthesiologists resist performing ophthalmic regional blocks because they lack formal training. In future, anesthesiologists will need to block eyes and manage common medical conditions because economic pressures will eliminate routine preoperative testing. This review addresses a variety of topical issues in ophthalmic anesthesia with special emphasis on cannula and needle-based blocks and the new-generation antithrombotic agents. In a constantly evolving arena, the sub-Tenon’s block has gained popularity while the deep angulated intraconal (retrobulbar block has been largely superseded by the shallower extraconal (peribulbar approach. Improvements in surgical technique have also impacted anesthetic practice. For example, phacoemulsification techniques facilitate the conduct of cataract surgery under topical anesthesia, and suture-free vitrectomy ports may cause venous air embolism during air/fluid exchange. Hyaluronidase is a useful adjuvant because it
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Neuro-ophthalmic and clinical characteristics of brain tumours in a ...
African Journals Online (AJOL)
Background: Anecdotally, increasing number of patients are seen at Korle Bu Teaching Hospital (KBTH) with brain tumour. Neuro-ophthalmic symptoms and signs may help in timely diagnosis and intervention. Objective: To evaluate the neuro-ophthalmic and clinical characteristics of brain tumour in patients presenting at a ...
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Ophthalmic artery color Doppler ultrasonography in mild-to-moderate preeclampsia
Energy Technology Data Exchange (ETDEWEB)
Ayaz, Tunahan; Akansel, Gur. E-mail: gakansel@superonline.com; Hayirlioglu, Alper; Arslan, Arzu; Suer, Necdet; Kuru, Ihsan
2003-06-01
Objective: To evaluate the hemodynamic changes in mild-moderate preeclampsia using ophthalmic artery Doppler ultrasonography technique. Methods: Ophthalmic artery pulsatility and resistivity indices were calculated in 30 mild-moderate preeclamptic women and 30 normotensive gravid women of matched gestational age. Student's t-test was performed to test the significance of difference. Results: Both indices of peripheral resistance were found to be significantly lower in the ophthalmic arteries of mild-moderately preeclamptic women than those measured in normotensive gravid women at similar stage of pregnancy. In a small number patients whose disease progressed to severe preeclampsia, both indices increased. Conclusion: In patients with mild-moderate preeclampsia, ophthalmic artery color Doppler ultrasonography detects hemodynamic changes that are not present in normotensive gravid women. Reversal of Doppler patterns in a small number of patients with progressive disease supports the hypotheses suggesting the presence of early vasodilation and late vasospasm in the etiology of preeclampsia.
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Ophthalmic Drug Delivery in Glaucoma—A Review
Directory of Open Access Journals (Sweden)
Ingrida Januleviciene
2012-03-01
Full Text Available Glaucoma is a progressive optic neuropathy and medical therapy is the initial option for the treatment of this potentially blinding condition. Topical instillation of eye drops from the bottle is the most common glaucoma drug delivery form. Due to limited permeability of anterior ocular surface, natural clearance and drainage, eye drops contain large amounts of inactive ingredients. Effective penetration enhancers are known as irritants causing ocular discomfort. Although drug efficacy is determined by active ingredients, inactive agents can affect tolerance and can result in conjunctival irritation and hyperemia and influence patients’ adherence and quality of life.
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Herpes simplex virus ophthalmic disease induced using two different methods of mice inoculation
Directory of Open Access Journals (Sweden)
Sílvia Regina Ferreira Gonçalves Pereira
Full Text Available Two different procedures for inoculation of HSV on corneas of BALB/c mice were evaluated. The first was by the use of HSV suspensions directly on the corneas and the other was after corneal scarification. Animals by this later method presented greater morbidity and mortality than those of first group, suggesting that inoculation of HSV without scarification of the cornea should be the method of choice for the study of HSV ophthalmic infection. This model showed also be an efficient experimental system to testing antiviral drugs.
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CHECKPOINT INHIBITOR IMMUNE THERAPY: Systemic Indications and Ophthalmic Side Effects.
Dalvin, Lauren A; Shields, Carol L; Orloff, Marlana; Sato, Takami; Shields, Jerry A
2018-06-01
To review immune checkpoint inhibitor indications and ophthalmic side effects. A literature review was performed using a PubMed search for publications between 1990 and 2017. Immune checkpoint inhibitors are designed to treat system malignancies by targeting one of three ligands, leading to T-cell activation for attack against malignant cells. These ligands (and targeted drug) include cytotoxic T-lymphocyte antigen-4 (CTLA-4, ipilimumab), programmed death protein 1 (PD-1, pembrolizumab, nivolumab), and programmed death ligand-1 (PD-L1, atezolizumab, avelumab, durvalumab). These medications upregulate the immune system and cause autoimmune-like side effects. Ophthalmic side effects most frequently manifest as uveitis (1%) and dry eye (1-24%). Other side effects include myasthenia gravis (n = 19 reports), inflammatory orbitopathy (n = 11), keratitis (n = 3), cranial nerve palsy (n = 3), optic neuropathy (n = 2), serous retinal detachment (n = 2), extraocular muscle myopathy (n = 1), atypical chorioretinal lesions (n = 1), immune retinopathy (n = 1), and neuroretinitis (n = 1). Most inflammatory side effects are managed with topical or periocular corticosteroids, but advanced cases require systemic corticosteroids and cessation of checkpoint inhibitor therapy. Checkpoint inhibitors enhance the immune system by releasing inhibition on T cells, with risk of autoimmune-like side effects. Ophthalmologists should include immune-related adverse events in their differential when examining cancer patients with new ocular symptoms.
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Directory of Open Access Journals (Sweden)
M. I. Razumovsky
2014-07-01
Full Text Available Aim was to analyze working capacities of visually impaired persons by means of complex electrophysiological and ophthalmic ergonomics eye examination.Materials and methods. Standard clinical ophthalmologic examination (visual acuity measurement, refractometry, biomicroscopy, ophthalmoscopy as well as electrophysiological (electrooculography, electrical sensitivity of the eye, critical flicker fusion frequency and ophthalmic ergonomics tests (accommodation measurement, professional testing using automated system «Proftest-1» were performed.Results. Complex electrophysiological and ophthalmic ergonomics tests were performed in 20 visually impaired persons. Their results revealed direct correlation between electrophysiological and ophthalmic ergonomics indices.Conclusion. Working capacities of visually impaired persons can be assessed reliably using complex electrophysiological and ophthalmic ergonomics eye examination only.
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Directory of Open Access Journals (Sweden)
M. I. Razumovsky
2014-01-01
Full Text Available Aim was to analyze working capacities of visually impaired persons by means of complex electrophysiological and ophthalmic ergonomics eye examination.Materials and methods. Standard clinical ophthalmologic examination (visual acuity measurement, refractometry, biomicroscopy, ophthalmoscopy as well as electrophysiological (electrooculography, electrical sensitivity of the eye, critical flicker fusion frequency and ophthalmic ergonomics tests (accommodation measurement, professional testing using automated system «Proftest-1» were performed.Results. Complex electrophysiological and ophthalmic ergonomics tests were performed in 20 visually impaired persons. Their results revealed direct correlation between electrophysiological and ophthalmic ergonomics indices.Conclusion. Working capacities of visually impaired persons can be assessed reliably using complex electrophysiological and ophthalmic ergonomics eye examination only.
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Jenke, Dennis; Castner, James; Egert, Thomas; Feinberg, Tom; Hendricker, Alan; Houston, Christopher; Hunt, Desmond G; Lynch, Michael; Shaw, Arthur; Nicholas, Kumudini; Norwood, Daniel L; Paskiet, Diane; Ruberto, Michael; Smith, Edward J; Holcomb, Frank
2013-01-01
Polymeric and elastomeric materials are commonly encountered in medical devices and packaging systems used to manufacture, store, deliver, and/or administer drug products. Characterizing extractables from such materials is a necessary step in establishing their suitability for use in these applications. In this study, five individual materials representative of polymers and elastomers commonly used in packaging systems and devices were extracted under conditions and with solvents that are relevant to parenteral and ophthalmic drug products (PODPs). Extraction methods included elevated temperature sealed vessel extraction, sonication, refluxing, and Soxhlet extraction. Extraction solvents included a low-pH (pH = 2.5) salt mixture, a high-pH (pH = 9.5) phosphate buffer, a 1/1 isopropanol/water mixture, isopropanol, and hexane. The resulting extracts were chemically characterized via spectroscopic and chromatographic means to establish the metal/trace element and organic extractables profiles. Additionally, the test articles themselves were tested for volatile organic substances. The results of this testing established the extractables profiles of the test articles, which are reported herein. Trends in the extractables, and their estimated concentrations, as a function of the extraction and testing methodologies are considered in the context of the use of the test article in medical applications and with respect to establishing best demonstrated practices for extractables profiling of materials used in PODP-related packaging systems and devices. Plastic and rubber materials are commonly encountered in medical devices and packaging/delivery systems for drug products. Characterizing the extractables from these materials is an important part of determining that they are suitable for use. In this study, five materials representative of plastics and rubbers used in packaging and medical devices were extracted by several means, and the extracts were analytically
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Gong, Lan; Sun, Xinghuai; Ma, Zhizhong; Wang, Qinmei; Xu, Xun; Chen, Xiaoming; Shao, Yan; Yao, Ke; Tang, Luosheng; Gu, Yangshun; Yuan, Huiping; Chua, Wei Han; Chuan, Jacob Cheng Yen; Tong, Louis
2015-07-01
To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in patients with dry eye in China and Singapore. A total of 497 patients with dry eye (Schirmer's test, 5 mm; fluorescein and RB score, 3 points) from China and Singapore were randomised to receive either diquafosol ophthalmic solution (diquafosol) or sodium hyaluronate ophthalmic solution (HA) at 1:1 ratio. The fluorescein staining scores and rose bengal (RB) subjective symptom scores and tear film breakup time were evaluated before treatment and 2 and 4 weeks after start of treatment. In the diquafosol group, changes in fluorescein and RB scores compared with baseline at week 4 or at the time of discontinuation were -2.1±1.5 and -2.5±2.0, respectively. Compared with the HA group, changes in fluorescein score were non-inferior and changes in RB score were superior (p=0.019). In addition, diquafosol and HA improved tear film breakup time by 1.046±1.797 and 0.832±1.775 s, respectively (no significant intergroup difference). Adverse event onset rates were 16.3% (40 of 246 subjects) and 10.0% (25 of 251 subjects) in the diquafosol group and HA group, respectively, with borderline significant intergroup differences (p=0.046), while adverse drug reaction incidence rates were 12.2% (30 of 246 subjects) and 6.0% (15 of 251 subjects), respectively (p=0.019). Only mild adverse drug reactions (>2%) in the form of eye discharge, itching or irritation were observed. Diquafosol improved fluorescein staining score in a manner similar to HA, and significantly improved RB score compared with HA. NCT01101984. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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Challenges Encountered Using Ophthalmic Anesthetics in Space Medicine
Bayuse, T.; Law, J.; Alexander, D.; Moynihan, S.; LeBlanc, C.; Langford, K.; Magalhaes, L.
2015-01-01
On orbit, ophthalmic anesthetics are used for tonometry and off-nominal corneal examinations. Proparacaine has been flown traditionally. However, the manufacturers recently changed its storage requirements from room temperature storage to refrigerated storage to preserve stability and prolong the shelf-life. Since refrigeration on orbit is not readily available and there were stability concerns about flying proparacaine unrefrigerated, tetracaine was selected as an alternative ophthalmic anesthetic in 2013. We will discuss the challenges encountered flying and using these anesthetics on the International Space Station.
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Profiling extractable and leachable inorganic impurities in ophthalmic drug containers by ICP-MS.
Solomon, Paige; Nelson, Jenny
2018-03-01
In this study, we investigated the elemental impurities present in the plastic material of ophthalmic eye drop bottles using inductively coupled plasma-mass spectrometry (ICP-MS). Metallic contaminations, especially localized within the small cavity of the eye, can significantly perturb the ocular metallome. The concern is two-fold: first certain elements, for example heavy metals, can be toxic to humans at even trace levels, and second, these contaminations can have adverse reactions with other medicines or enzymatic processes in the eye. The implication of redox-active metals in cataract formation is one such biological consequence. The analysis demonstrated the effect of aggressive storage and transportation conditions on elemental extractable and leachable contamination, and posits that release of these elemental impurities can disrupt metallome equilibrium in the ocular compartment, leading to toxicity and disease.
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Ocular Insert: Dosage Form for Sustain Opthalmic Drug Delivery
Directory of Open Access Journals (Sweden)
Sunil Kumar
2012-06-01
Full Text Available Except for skin, the eye is the most easily accessible site for topical administration of a medication. Traditional topical ophthalmic formulations (eye drops and ointments have poor bioavailability because of rapid pre-corneal elimination, conjunctival absorption, solution drainage by gravity, induced lacrimation and normal tear turnover. This leads to frequent installations of concentrated medication to achieve a therapeutic effect. The typical “pulse-entry” type drug release observed with ocular aqueous solutions (eye drops, suspensions and ointments can be replaced by more controlled, sustained, and continuous drug delivery, using a controlled-release ocular drug delivery system. Ocular inserts are solid or semisolid sterile preparations, of appropriate size and shape, designed to be inserted behind the eyelid or held on the eye and to deliver drugs for topical or systemic effect. These are polymeric systems into which the drug is incorporated as a solution or dispersion. They are better tolerated as to drainage and tear flow compared with other ophthalmic formulation and produce reliable drug release in the conjunctival cul-de-sac.
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Lee, Andrew G; Golnik, Karl C; Tso, Mark O M; Spivey, Bruce; Miller, Kathleen; Gauthier, Tina-Marie
2012-10-01
To describe the emerging strategic global perspective of the International Council of Ophthalmology (ICO) efforts in ophthalmic education. A global perspective describing how the development of sophisticated educational tools in tandem with information technology can revolutionize ophthalmic education worldwide. Review of ICO educational tools, resources, and programs that are available to ophthalmic educators across the globe. With the explosive growth of the Internet, the ability to access medical information in the most isolated of locations is now possible. Through specific ICO initiatives, including the ICO curricula, the "Teaching the Teachers" program, and the launching of the new ICO Center for Ophthalmic Educators, the ICO is providing ophthalmic educators across the globe with access to standardized but customizable educational programs and tools to better train ophthalmologists and allied eye care professionals throughout the world. Access to educational tools and strengthening of global learning will help providers meet the goals of VISION 2020 and beyond in eliminating avoidable blindness. It is the intent of the ICO that its programs for ophthalmic educators, including conferences, courses, curricula, and online resources, result in better-trained ophthalmologists and eye care professionals worldwide. Copyright © 2012 Elsevier Inc. All rights reserved.
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Sakata, Rei; Sakisaka, Toshihiro; Matsuo, Hiroshi; Miyata, Kazunori; Aihara, Makoto
2016-03-01
It is reported that nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution affected the therapeutic efficacy of prostaglandin (PG) analog by inhibiting endogenous PG production. However, whether NSAID ophthalmic solution interferes with its conjunctival hyperemia is unknown. We investigated the effect of NSAID ophthalmic solution on its hyperemia. This was a prospective, randomized, double-blind, placebo-controlled 1-month trial. Benzalkonium chloride-free travoprost 0.004% was used as a PG analog and administered once daily (08:00) in both eyes. Bromfenac sodium hydrate was assigned randomly to 1 eye twice daily (08:00 and 20:00) (the NSAID side), whereas flavin adenine dinucleotide sodium was applied to the fellow eye of each patient twice daily (08:00 and 20:00) (the control side). Conjunctival photographs of both eyes were taken 3 times (08:00, 14:00, 20:00) on days 1, 2, 7, and 28, and hyperemia was scored from 0 to 5 (H-score). We compared H-scores on the NSAID and control sides. Twenty-eight Japanese normal subjects completed the study. The H-score on the NSAID side was significantly lower than that on the control side on day 1 at 14:00 (P=0.016, paired t test) and day 2 at 14:00 (P=0.016). But there were no differences at 20:00 on each day and after that time. The use of NSAID ophthalmic solution had almost no impact on PG analog-related conjunctival hyperemia. This partly suggests that the action mechanism of endogenous PG after administrating PG analog might be no correlation with conjunctival hyperemia.
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Kim, Yong-Kyu; Jung, Cheolkyu; Woo, Se Joon; Park, Kyu Hyung
2015-01-01
Cosmetic facial filler-related ophthalmic artery occlusion is rare but is a devastating complication, while the exact pathophysiology is still elusive. Cerebral angiography provides more detailed information on blood flow of ophthalmic artery as well as surrounding orbital area which cannot be covered by fundus fluorescein angiography. This study aimed to evaluate cerebral angiographic features of cosmetic facial filler-related ophthalmic artery occlusion patients. We retrospectively reviewed...
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78 FR 60884 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2013-10-02
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Immunoregulation, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics...
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76 FR 13646 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2011-03-14
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review...
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76 FR 44016 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2011-07-22
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research...
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Safety in the use of compressed air versus oxygen for the ophthalmic patient.
Rodgers, Laura A; Kulwicki, Anahid
2002-02-01
Oxygen, routinely administered during surgery to avoid hypoxia, poses risks including increased likelihood of surgical room fires and predisposition to retinal phototoxicity in patients. Compressed air to supplement ventilation may be safer than oxygen. The purpose of this study was to determine whether hypoxia occurs more frequently when compressed air replaces supplemental oxygen during ophthalmic surgery. A convenience sample of 111 patients was randomly assigned to receive supplemental oxygen (group 1) or compressed air (group 2). Patients with serious cardiac or pulmonary disease were excluded. Blood oxygen levels were monitored during surgery by pulse oximetry. Oxygen was administered to all group 2 patients whose oxygen saturation fell to less than 90% or by more than 5% below baseline. No differences were observed between groups in age, ASA classification, type of surgery, or anesthetic drugs or doses. Minor, but statistically higher oxygen values were observed in group 1. The frequency with which oxygen saturation decreased below 90% or below 5% of baseline was similar in both groups. Supplemental oxygen is not required routinely in selected patients undergoing ophthalmic surgery. By using compressed air, the risk of operating room fires and retinal phototoxicity may be reduced.
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21 CFR 14.40 - Establishment and renewal of advisory committees.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Establishment and renewal of advisory committees. 14.40 Section 14.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., color, national origin, religion, age, or sex. (3) It is constituted and utilizes procedures designed to...
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77 FR 42319 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2012-07-18
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... consideration of the appropriateness of cell lines derived from human tumors for vaccine manufacture. FDA...
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77 FR 3780 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2012-01-25
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The...
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75 FR 59729 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2010-09-28
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... vaccines for a post-exposure prophylaxis indication using the animal rule. On November 17, 2010, the...
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78 FR 20663 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2013-04-05
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function..., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends to...
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76 FR 55397 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2011-09-07
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center...
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2010-03-11
...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive...
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Risk factors of ophthalmic disorders in children with developmental delay
DEFF Research Database (Denmark)
Sandfeld, L.N.; Jensen, H.; Skov, L.
2008-01-01
PURPOSE: To identify diagnoses that increase the risk of ophthalmic disorders in developmentally delayed children. METHODS: A cross-sectional study of 1126 Danish children with developmental delay (IQ Udgivelsesdato: 2008/12......PURPOSE: To identify diagnoses that increase the risk of ophthalmic disorders in developmentally delayed children. METHODS: A cross-sectional study of 1126 Danish children with developmental delay (IQ Udgivelsesdato: 2008/12...
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Golnik, Karl; Mayorga, Eduardo; Spivey, Bruce; Ritch, Robert; Gauthier, Tina-Marie
2012-01-01
The International Council of Ophthalmology (ICO) is a global organization with a regional focus. Working in partnership with supranational and ICO member societies, the ICO is building a "World Alliance for Sight" to improve access to the highest-quality eye care worldwide. Designed to preserve and restore vision on an international scale, the ICO initiative, "Refocusing Ophthalmic Education," enhances ophthalmic education of residents, subspecialists, medical students, and allied eye care personnel by redefining the most effective ways to teach and in creating beneficial educational opportunities. The "Teaching the Teachers" program helps ophthalmic educators incorporate more effective methods of training and continuing professional development to meet societal needs, achieved in part through regional courses for residency program directors; symposia, and keynote talks presented by ICO's World Ophthalmology Educational Colloquium, Conferences for Ophthalmic Educators, and ophthalmic surgical competency rubrics. Recognizing that standardized curricula are essential for consistent ophthalmic education, the ICO has developed a curricular framework whereby goals, expectations, knowledge base, competencies, and technical training are delineated. The ICO is defining worldwide models of team training and compiling best practice, which will include training-program accreditation to ensure improvement in the education of ophthalmologists. International Council of Ophthalmology Web-based teaching courses, a Webinar Network, and a technology blog further support information and communication technologies for teaching and learning. At the ICO's Center for Ophthalmic Educators (educators.icoph.org), trainers will find valuable teaching resources in multiple languages as well as ways to share ideas and collaborate with peers and other ophthalmic educators.
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21 CFR 14.35 - Written submissions to an advisory committee.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Written submissions to an advisory committee. 14.35 Section 14.35 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... of the written summary along with a proposed agenda outlining the topics to be covered and...
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77 FR 63839 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2012-10-17
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide...) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November 15, 2012, the committee will meet...
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75 FR 2876 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2010-01-19
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... virus vaccine for the 2010 - 2011 influenza season. FDA intends to make background material available to...
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76 FR 3639 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2011-01-20
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... the influenza virus vaccine for the 2011-2012 influenza season. The committee will also hear an update...
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78 FR 5465 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2013-01-25
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... virus vaccine for the 2013- 2014 influenza season. FDA intends to make background material available to...
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78 FR 44133 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2013-07-23
...] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide... documents issued from the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and...
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76 FR 22405 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2011-04-21
...] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide... June 29, 2011, the committee will discuss cellular and gene therapy products for the treatment of...
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78 FR 79699 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting
2013-12-31
...] Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue, and Gene Therapies Advisory Committee. General Function of the Committee: To provide... updates on guidance documents issued from the Office of Cellular, Tissue, and Gene Therapies, Center for...
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2013-05-13
...] Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5%, Was Not Withdrawn From Sale... ophthalmic solution), 0.5%, was not withdrawn from sale for reasons of safety or effectiveness. This... ophthalmic solution, 0.5%, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION...
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Hsu, Kimberly K; Pinard, Chantale L; Johnson, Ron J; Allen, Dana G; KuKanich, Butch K; Nykamp, Stephanie G
2015-03-01
To quantify plasma concentrations and determine adverse ocular, renal, or hepatic effects associated with repeated topical ophthalmic application of 0.1% diclofenac to healthy cats. 8 healthy sexually intact male cats. A randomized, placebo-controlled crossover study was conducted. A topical formulation of 0.1% diclofenac was administered 4 times/d for 7 days to 4 cats, and artificial tear (control) solution was administered to the other 4 cats. After a 12-day washout period, cats received the other treatment. Ophthalmic examinations were performed daily. Plasma samples were obtained on days 1 and 7 for pharmacokinetic analysis. A CBC, serum biochemical analysis, urinalysis, determination of urine protein-to-creatinine ratio, and determination of glomerular filtration rate were performed before the start of the study and after each 7-day treatment period. Mild conjunctival hyperemia was the only adverse ocular effect detected. Maximal drug concentration and area under the curve were significantly higher on day 7 than on day 1. Diclofenac-treated cats had a significantly lower glomerular filtration rate than did control-treated cats after the second but not after the first treatment period, presumably associated with iatrogenic hypovolemia. Topical ophthalmic administration of 0.1% diclofenac was well tolerated in healthy cats, with only mild signs of ocular irritation. Detectable systemic concentrations of diclofenac were achieved with accumulation over 7 days. Systemic absorption of diclofenac may be associated with reduced glomerular filtration rate, particularly in volume-contracted animals. Topical ophthalmic 0.1% diclofenac should be used with caution in volume-contracted or systemically ill cats.
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Directory of Open Access Journals (Sweden)
Morris TW
2011-09-01
Full Text Available Timothy W Morris1, Lynne S Gearinger1, Dale W Usner2, Michael R Paterno2, Heleen H DeCory3, Timothy L Comstock3, Wolfgang Haas11Microbiology and Sterilization Sciences, 2Clinical Affairs, 3Global Pharmaceutical Medical Affairs, Bausch & Lomb, Rochester, NY, USAPurpose: To assess clinical antimicrobial efficacy results obtained with besifloxacin ophthalmic suspension, 0.6%, administered three times a day (TID for 5 days, integrated across three clinical trials of bacterial conjunctivitis and to investigate any microbiological eradication failures.Methods: Clinical microbiological eradication data from three randomized, double-masked, parallel group studies of patients with bacterial conjunctivitis (two vehicle controlled; one active controlled with moxifloxacin ophthalmic solution, 0.5% were integrated. All bacterial samples isolated at baseline above the species-specific threshold value were subjected to antimicrobial susceptibility testing. Samples isolated at subsequent visits were subjected to susceptibility testing and pulsed-field gel electrophoresis (PFGE to investigate the cause of eradication failures and the potential for drug resistance development.Results: Visit 2 (day 4 or 5 and visit 3 (day 8 overall microbiological eradication rates were 92.2% and 88.4% for besifloxacin ophthalmic suspension compared with 61.4% and 72.5% for vehicle and 91.6% and 85.7% for moxifloxacin ophthalmic solution. Visit 2 and visit 3 microbiological eradication rates for Gram-positive and Gram-negative isolates and for individual species were consistent with the overall eradication rates. The majority of observed eradication failures in any treatment group were due to the persistence of the pathogen isolated at baseline. Eradication failures in the besifloxacin treatment group were not associated with lower antimicrobial susceptibility at baseline. PFGE data showed that the majority of bacterial strains in eyes with eradication failures were identical to
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2010-03-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2011-01-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2013-07-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2012-07-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2012-07-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2012-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2010-02-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0067] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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Comparison of the effectiveness of contemporary ophthalmic lenses against β radiation
International Nuclear Information System (INIS)
Dunlap, J.H.; Harvey, P.W.; Schwing, R.L.
1977-01-01
As part of a study intended to identify the lens material and type that provides maximum eye protection against beta radiation, the effectiveness of contemporary ophthalmic lenses has been evaluated. From the calculations and measurements presented it is evident that safety glasses with crown glass ophthalmic lenses afford the eye the greatest protection against beta radiation, whereas street glasses with plastic ophthalmic lenses afford the eye very little protection. It is to be noted that glass street lenses (approximately 2.2 mm thick) provide greater protection than plastic safety lenses (approximately 3.5 mm thick). A warning is given against the use of safety lenses containing a large percentage of thorium. (U.K.)
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78 FR 70954 - Risk Communications Advisory Committee; Notice of Meeting
2013-11-27
... awareness and understanding of the key risk messages, as well as whether the communications are having the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Risk Communications Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...
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A Profile of Neuro-Ophthalmic Practice Around the World.
Frohman, Larry P
2018-03-01
To compare contrast neuro-ophthalmic practice in various countries, an 18-question survey was sent to the international North American Neuro-Ophthalmology Society (NANOS) members in the spring of 2016. At least 1 NANOS member was contacted for each non-US nation in the NANOS membership roster. If there were multiple NANOS members from 1 country, multiple were contacted. If responses were received from more than 1 person from a single country, the first response received was used as the source data. The survey (in English) was emailed to 47 NANOS members from 31 countries. Twenty responses were received representing members from 15 nations. In all 15 nations, at least half of the neuro-ophthalmologists were trained as ophthalmologists. In 60% of nations, at least half of the neuro-ophthalmologists were trained internally, whereas in 33% of countries, at least half were trained in the United States. The number of physicians who practiced a significant amount of neuro-ophthalmology ranged from low (0.08/million, India) to high (3.10/million, Israel). Countries having the highest percentage of neuro-ophthalmologists exclusively practicing neuro-ophthalmology also were those with better patient access to neuro-ophthalmic care. Requirement of approval to see a neuro-ophthalmologist or for imaging studies requested by neuro-ophthalmologists was not typical. In most nations, academic neuro-ophthalmologists were paid a straight salary. In no nation were neuro-ophthalmologists paid more than another ophthalmic subspecialty. Individual national health care system designs and compensation models have had a profound influence on the rewards and challenges that face neuro-ophthalmologists. There seems to have been a connection between recognition of the discipline, financial rewards of neuro-ophthalmic practice, conditions that permit full-time neuro-ophthalmic practice, and patient access to care. A higher percentage of gross national product for health care did not seem to
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76 FR 59404 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting
2011-09-26
..., efficacy, and durability of response with repeat treatment cycles of XIFAXAN (rifaximin), by Salix Pharmaceuticals, Inc., for irritable bowel syndrome with diarrhea. FDA intends to make background material...Committees/Calendar/default.htm . Scroll down to the appropriate advisory committee link. Procedure...
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Nanoparticles laden in situ gelling system for ocular drug targeting
Directory of Open Access Journals (Sweden)
Divya Kumar
2013-01-01
Full Text Available Designing an ophthalmic drug delivery system is one of the most difficult challenges for the researchers. The anatomy and physiology of eye create barriers like blinking which leads to the poor retention time and penetration of drug moiety. Some conventional ocular drug delivery systems show shortcomings such as enhanced pre-corneal elimination, high variability in efficiency, and blurred vision. To overcome these problems, several novel drug delivery systems such as liposomes, nanoparticles, hydrogels, and in situ gels have been developed. In situ-forming hydrogels are liquid upon instillation and undergo phase transition in the ocular cul-de-sac to form viscoelastic gel and this provides a response to environmental changes. In the past few years, an impressive number of novel temperature, pH, and ion-induced in situ-forming systems have been reported for sustain ophthalmic drug delivery. Each system has its own advantages and drawbacks. Thus, a combination of two drug delivery systems, i.e., nanoparticles and in situ gel, has been developed which is known as nanoparticle laden in situ gel. This review describes every aspects of this novel formulation, which present the readers an exhaustive detail and might contribute to research and development.
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78 FR 48438 - Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting
2013-08-08
...] Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of Subcommittee: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee. General Function... pediatric ethical issues. Date and Time: The meeting will be held on September 9, 2013, from 8 a.m. to 5:30...
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21 CFR 14.20 - Notice of hearing before an advisory committee.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Notice of hearing before an advisory committee. 14.20 Section 14.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... function of the committee; (4) A list of all agenda items, showing whether each will be discussed in an...
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78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination
2013-11-22
.... FDA-2013-N-1380] Advisory Committee; Veterinary Medicine Advisory Committee; Termination AGENCY: Food... announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the Veterinary Advisory Committee from the Agency's list of standing advisory committees. DATES: This rule is...
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Kumar, Anupma; Cheeseman, Robert; Durnian, Jonathan M
2011-06-01
To investigate the publishing trends of the top general clinical ophthalmic journals and to report: (1) the proportions of articles published in terms of ophthalmic subspecialty, (2) the study design used, (3) any changes in publishing trends, and (4) any differences in the quality of study design between the subspecialties. Retrospective, database review. All original articles published in the top general, clinical ophthalmology journals from 2005 through 2009. All general, clinical ophthalmic journals were selected from the top 20 journals based on 2008 impact factor. All abstracts from original articles were reviewed, and the subject matter was recorded as belonging to 1 of the 11 ophthalmic subspecialties. After the content of the article was assigned, then the study design was recorded as one of the following: nonanalytic study, case-control or cohort study, randomized control trial, meta-analysis, laboratory science article, or systemic review. Subspecialty of the article and the study design used. Seven journals were included, and 12 426 abstracts were reviewed. Articles relating to medical retina were the most prevalent (29.1%), and those relating to strabismus were the least prevalent (2.3%). Case-control or cohort studies comprised most study designs (40.1%), with meta-analyses comprising the least (0.3%). The mean number of articles per year was 2485 (standard deviation, 125.1), remaining stable over the study period. Medical retina articles were significantly more common in 2009 than in 2005 (chi-square, 11.2; P = 0.0008), whereas the proportion of oculoplastic articles was significantly reduced (chi-square, 16.9; P<0.0001). Cataract and refractive surgery had the highest proportions of articles using the higher forms of study design (7.8%), and oculoplastics had the highest proportion of nonanalytic studies (64.5%). There are great differences across the specialty of ophthalmology in the subject matter of published literature, probably driven by recent
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Ophthalmic Start-Up Chief Executive Officers' Perceptions of Development Hurdles.
Stewart, William C; Nelson, Lindsay A; Kruft, Bonnie; Stewart, Jeanette A
2018-01-01
To identify current challenges facing ophthalmic pharmaceutical start-ups in developing new products. Surveys were distributed to the chief executive officer (CEO) or president of ophthalmic start-ups. The survey attracted 24 responses from 78 surveys distributed (31%). The CEOs stated that a lack of financial capital (n = 18, 75%), FDA regulations (n = 6, 25%), and failure to meet clinical endpoints (n = 6, 25%) were their greatest development hurdles. Risk aversion to medicines in early development (n = 18, 75%), mergers and acquisitions reducing corporate choice for licensing agreements (n = 7, 29%), the emergence of large pharmaceutical-based venture capital funding groups (n = 12, 50%), and the failure of many large pharmaceutical companies to develop their own medicines (n = 10, 42%) were noted as recent prominent trends affecting fundraising. The study suggests that development funding, regulatory burden, and meeting clinical endpoints are the greatest development challenges faced by ophthalmic start-up CEOs. © 2017 S. Karger AG, Basel.
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Formulation and stability of an extemporaneous 0.02% chlorhexidine digluconate ophthalmic solution
Directory of Open Access Journals (Sweden)
Shu-Chiao Lin
2015-12-01
Conclusion: The acetate-buffered 0.02% chlorhexidine digluconate ophthalmic solution stored in light-resistant high-density polyethylene eyedroppers demonstrated excellent stability at 2–25°C for 6 months after being sealed and for 1 month after opening. This finding will enable us to prepare 0.02% chlorhexidine digluconate ophthalmic solutions based on a doctor's prescription.
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78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting
2013-05-13
...] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the...
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The ocular distribution of 14C-labeled bromfenac ophthalmic solution 0.07% in a rabbit model
Directory of Open Access Journals (Sweden)
Baklayan GA
2014-09-01
Full Text Available George A Baklayan, Mauricio Muñoz Bausch + Lomb, Irvine, CA, USA Purpose: To evaluate the ocular distribution of an advanced formulation of bromfenac ophthalmic solution. Two studies were conducted in rabbits: 1 a 12-hour parallel-group study comparing the ocular distribution of 14C-bromfenac ophthalmic solution 0.07%, pH 7.8 with that of 14C-bromfenac ophthalmic solution 0.09%, pH 8.3, and 2 a 24-hour study evaluating the ocular distribution of 14C-bromfenac ophthalmic solution 0.07%, pH 7.8.Methods: In the 12-hour study, rabbits were randomized to receive 50 µL of 14C-bromfenac 0.07%, pH 7.8 or 50 µL 14C-bromfenac 0.09%, pH 8.3 in one eye, whereas, in the 24-hour, study both eyes received 50 µL of 14C-bromfenac 0.07%, pH 7.8. Ocular tissues were collected at 1, 2, 4, 8, 12 (both studies and 24 hours (second study only following drug instillation, and tissue radioactivity was determined using liquid scintillation chromatography. Results: Measureable levels of bromfenac were observed in all ocular tissues, with the exception of vitreous humor, regardless of formulation. In the 12-hour study, high concentrations of 14C-bromfenac were found in the sclera, followed by the iris/ciliary body, aqueous humor, choroid, retina, and lens. There was no significant difference between the bromfenac 0.07%, pH 7.8 and bromfenac 0.09%, pH 8.3 formulations in any 14C-bromfenac tissue levels at any time point, with the exception of in sclera at 2 hours post-instillation (0.451 µg eq/g versus 0.302 µg eq/g, respectively, P<0.001. There was also no significant difference in the total amount of 14C-bromfenac in the tissues evaluated following instillation of the two formulations. In the 24-hour study evaluating bromfenac 0.07%, pH 7.8 only, high concentrations of 14C-bromfenac were found 1 hour post-instillation in the cornea (2.402 µg eq/g and conjunctiva (1.049 µg eq/g, two tissues not evaluated in the 12-hour study. The rank order of 14C
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Geenen, S.; Yates, J.W.T.; Kenna, J.G.; Bois, F.Y.; Wilson, I.D.; Westerhoff, H.V.
2014-01-01
A key role of the antioxidant glutathione is detoxification of chemically reactive electrophilic drug metabolites within the liver. Therefore glutathione depletion can have severe toxic consequences. Ophthalmic acid and 5-oxoproline are metabolites involved in glutathione metabolism, which can be
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Tso, Mark O M; Goldberg, Morton F; Lee, Andrew G; Selvarajah, Sivaguru; Parrish, Richard K; Zagorski, Zbigniew
2007-05-01
To highlight the four International Curricula of Ophthalmic Education developed by the Task Forces of the International Council of Ophthalmology, published in Klinische Monatsblätter für Augenheilkunde in November 2006. A global perspective of developing educational curricula as tools to improve eye care. Review of the experience and conclusions of the four international panels. The Task Force on Resident and Specialist Education developed a curriculum consisting of 15 topics in basic, standard, and advanced levels to provide flexibility of educational programs of the ophthalmic specialist in different locations across the world. The curricula were designed to be an educational tool to stimulate multiple levels of training of the ophthalmic specialist. The Task Force on Ophthalmic Education of Medical Students designed a curriculum covering 11 topics and provides illustrative materials for teachers and students. The Task Force strongly advocates the ophthalmology curriculum to be part of the core program of general medical schools education. The Task Force on Para-ophthalmic Vision Specialist Education developed a curriculum to highlight the importance of a team approach to eye care, consisting of ophthalmic specialists and paraophthalmic personnel to produce maximum efficiency. The Task Force on Continuing Medical Education (CME) designed a curriculum exploring the principles, elements, categories, and administration of CME activities in a variety of topics. These curricula shifted the traditional apprentice system of education to a curriculum-based training program in which goals, expectations, competencies, and technical training are defined to improve eye care worldwide.
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77 FR 50701 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting
2012-08-22
... always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down... (teduglutide) for subcutaneous injection, by NPS Pharmaceuticals, Inc, for the proposed indication of treatment of adult patients with short bowel syndrome. FDA intends to make background material available to the...
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Absorbed doses to the main parts of eyeball due to use 90Sr + 90Y ophthalmic applicator
International Nuclear Information System (INIS)
Chen Lishu
1993-05-01
The ophthalmic radiotherapy dosimetry and some affecting factors are introduced. The distributions of absorbed doses to the main parts of a fresh eyeball such as the cornea, sclera, lens and anterior chamber, during the radiotherapy by using a 90 Sr + 90 Y ophthalmic applicator are presented. An tissue-equivalent extrapolation ionization chamber was used in the dose measurement. The reasonable doses during ophthalmic radiotherapy for different depths have been obtained. Therefore, the absorbed dose to the lens, the most sensitive organ, can be given. These data are useful for radiation protection in ophthalmic radiotherapy
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2012-03-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...
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2011-11-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...
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Effect of textured eye drop bottles on the photostability of pranoprofen 0.1% ophthalmic solution.
Iwatsuka, Kinya; Inada, Katsuhiro; Ueoka, Hiroki; Otsuka, Tadashi; Maeda, Masaki; Yamaguchi, Masazumi; Yasueda, Shin-ichi
2015-01-01
Ophthalmic solutions are usually filled in a plastic bottle due to its durability and disposability. In Japan, photostability is one of the concerns for the quality control because an eye drop bottle must be a transparent container. The present work studied the effect of textured eye drop bottles on its light blocking to improve the photostability of ophthalmic solutions. We investigated the photostability of Pranoprofen ophthalmic solution filled in a variety of textured eye drop bottles. Pranoprofen content was analyzed by high-performance liquid chromatography and surface structure of textured eye drop bottles was evaluated by transmittance, calculated average roughness (Ra) and haze intensity. We observed that eye drop bottle which had greater than Ra value of 1.0 µm and haze intensity 62% clearly showed photostability improvement. This report is the first one which shows that photostability of ophthalmic solution is improved by using textured eye drop bottle. Moreover, this approach is a simple and effective method to improve the photostability. This method is available for not only various ophthalmic applications but also other liquid pharmaceuticals or food products.
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Dural AVM supplied by the ophthalmic artery.
LENUS (Irish Health Repository)
Flynn, T H
2012-02-03
Dural arteriovenous malformations in the anterior cranial fossa are rare and are especially prone to haemorrhage. These lesions are usually treated by surgical excision. We report the embolization of an anterior cranial fossa DAVM using an endovascular approach via the ophthalmic artery.
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Superior ophthalmic vein enlargement and increased muscle index in dysthyroid optic neuropathy.
Lima, Breno da Rocha; Perry, Julian D
2013-01-01
To compare superior ophthalmic vein diameter and extraocular muscle index in patients with thyroid eye disease with or without optic neuropathy. High-resolution CT scan images of 40 orbits of 20 patients with history of thyroid eye disease (with or without optic neuropathy), who underwent orbital decompression surgery from January 2007 to November 2009, were retrospectively reviewed. Superior ophthalmic vein diameter was measured in coronal and axial planes. Extraocular muscle index was calculated according to the method proposed by Barrett et al. The clinical diagnosis of optic neuropathy was based on characteristic signs that included afferent pupillary defect, decreased visual acuity, visual field defects, and dyschromatopsia. Orbits were divided in 2 groups based on presence or absence of optic neuropathy. Superior ophthalmic vein diameter was significantly higher in orbits with concomitant optic neuropathy (mean 2.4 ± 0.4mm, p optic neuropathy (mean 57.9% ± 5.7%, p = 0.0002). Muscle index greater than 50% was present in all patients with dysthyroid optic neuropathy. This study suggests that patients with thyroid eye disease with enlarged superior ophthalmic vein and increased extraocular muscle index are more likely to have concomitant optic neuropathy.
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Radioactivity measurements for some ophthalmic glasses
International Nuclear Information System (INIS)
Badawy, W.M.; Ali, E.M.; Gomaa, M.A.; Hussein, A
2007-01-01
The main aim of the present work is to implant the latest ICRP/IAEA recommendations related to exemption and clearness to the Ophthalmic Glass. As consumer product, glass lenses may contain trace quantities of uranium, thorium and potassium. Glass lenses under investigation were monitored for the detection of gamma rays and beta particles using radiation measuring devices. Using high purity germanium detector radioactivity concentration was estimated in Bq/kg. Activity concentration of 226 Ra, Th-232 and K-40 were determined using the energy gamma lines of 2l4 Pb (352 keV), 212 Pb (238 keV) and 1460 keV gamma line for 40 K respectively .Experimental results showed that radioactivity concentration for radium -226 varies from 0.19 to 4.98 Bq/kg of radium-226, from to 0.18 to 2.83 Bq/kg for thorium -232 and from 0.8 to 1.13 Bq/kg for potassium. Implementing new ICRP recommendation of exemption and clearness indicated that several Ophthalmic Glass should not be in use
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Effects of viscoelastic ophthalmic solutions on cell cultures
Directory of Open Access Journals (Sweden)
Madhavan Hajib
1998-01-01
Full Text Available The development of mild but significant inflammation probably attributable to viscoelastic ophthalmic solutions in cataract surgery was recently brought to the notice of the authors, and hence a study of the effects of these solutions available in India, on cell cultures was undertaken. We studied the effects of 6 viscoelastic ophthalmic solutions (2 sodium hyaluronate designated as A and B, and 4 hydroxypropylmethylcellulose designated as C, D, E and F on HeLa, Vero and BHK-21 cell lines in tissue culture microtitre plates using undiluted, 1:10 and 1:100 dilutions of the solutions, and in cover slip cultures using undiluted solutions. Phase contrast microscopic examination of the solutions was also done to determine the presence of floating particles. The products D and F produced cytotoxic changes in HeLa cell line and these products also showed the presence of floating particles under phase contrast microscopy. Other products did not have any adverse effects on the cell lines nor did they show floating particles. The viscoelastic ophthalmic pharmaceutical products designated D and F have cytotoxic effects on HeLa cell line which appears to be a useful cell line for testing these products for their toxicity. The presence of particulate materials in products D and F indicates that the methods used for purification of the solution are not effective.
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Stimuli-sensitive hydrogels: A novel ophthalmic drug delivery system
Directory of Open Access Journals (Sweden)
Singh Vinod
2010-01-01
Full Text Available Background: Stimuli-sensitive hydrogels are three-dimensional, hydrophilic, polymeric networks capable of imbibing large amounts of water or biological fluids on stimulation, such as pH, temperature and ionic change. Aim: To develop hydrogels that are sensitive to stimuli, i.e. pH, in the cul-de-sac of the eye for providing a prolonged effect and increased bioavailability with reduction in frequency of administration. Materials and Methods: Hydrogels were formulated by using timolol maleate as the model drug, polyacrylic acid as the gelling agents, hydroxyl ethyl cellulose as the viscolizer and sodium chloride as the isotonic agent. Stirring of ingredients in pH 4 phosphate buffer at high speed was carried out. The dynamic dialysis technique was used for drug release studies. In vivo study for reduction in intraocular pressure was carried out by using albino rabbits. Statistical Analysis: Drug release studies data were used for statistical analysis in first-order plots, Higuchi plots and Peppas exponential plots. Student t-test was performed for in vivo study. Results: Viscosity of the hydrogel increases from 3.84 cps to 9.54 cps due to change in pH 4 to pH 7.4. The slope value of the Peppas equation was found to be 0.3081, 0.3743 and 0.2964. Up to 80% of drug was released in an 8 h drug release study. Sterile hydrogels with no ocular irritation were obtained. Conclusions: Hydrogels show increase in viscosity due to change in pH. Hydrogels were therapeutically effacious, stable, non-irritant and showed Fickian diffusion. In vivo results clearly show a prolonged reduction in intraocular pressure, which was helpful for reduction in the frequency of administration.
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2011-09-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...
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Ophthalmic implications of seasonal affective disorder
International Nuclear Information System (INIS)
Paramore, J.E.; King, V.M.
1989-01-01
A review of seasonal affective disorder (SAD) is presented with a discussion of its standard treatment of phototherapy. A number of ophthalmic implications related to SAD are proposed. These implications relate to both the condition and the phototherapy used in its treatment, especially the use of full spectrum light which contains ultraviolet and near ultraviolet radiation. 12 references
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[Tibolone's effect on retinal and ophthalmic arteries flowmetry].
Souza, Marco Aurélio Martins de; Geber, Selmo
2008-11-01
to evaluate the effect of tibolone use on doppler-velocimetric parameters of ophthalmic and retinal arteries. clinical, prospective, longitudinal, randomized, placebo-controlled, triple-blind study, in which among 100 menopausal women, 50 have used 2.5 mg of the active principle tibolone (Tib Group) and 50, placebo as a means to form the control-group (Plac Group). In the Tib Group, 44 of the 50 women returned after 84 days to finish the exams, and in the Plac Group, 47. The ophthalmic and retinal arteries were studied to determine the resistance index (RI), the pulsatility index (PI) and the systole/diastole ratio (S/D). Assessments have been done before and 84 days after medication. The t-Student test has been used for the comparison of means between the groups in independent samples, as well as for within-group comparisons in dependent samples. in both groups, the women's characteristics were similar in age, menopause duration, body mass index, arterial blood pressure, deliveries and cardiac rate. The Tib Group presented the following values in the ophthalmic artery: RI(pre)=0.71+/-0.05, RI(post)0.72+/-0.08 (p=0.43); PI(pre)=1.29+/-0.22, PI(post)=1.30+/-0.25 (p=0.4) and S/D(pre)=3.49+/-0.77, SD(post)=3.65+/-0.94 (p=0.32). In the retinal artery, the following values have been found: RI(pre)=0.67+/-0.09, RI(post)=0.69+/-0.10 (p=0.7); PI(pre)=1.20+/-0.29, PI(post)=1.22+/-0.3 (p=0.2) and SD(pre)=3.29+/-0.95, SD(post)=3.30+/-1.07 (p=0.3). Also, the tibolone and control groups did not show any significant difference in regard to the above indexes in the end of the study. the 2.5 mg dose of tibolone had no effect on the Doppler velocimetry indexes of the ophthalmic and retinal arteries.
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Energy Technology Data Exchange (ETDEWEB)
Pham, Chi-Tuan; Blanc, Raphael; Pistocchi, Silvia; Bartolini, Bruno; Piotin, Michel [Fondation Rothschild Hospital, Department of Interventional Neuroradiology, Paris (France); Lumbroso-Le Rouic, Livia [Institut Curie, Department of Ocular Oncology, Paris (France)
2012-08-15
Intra-arterial infusion of chemotherapy into the ophthalmic artery for treatment of retinoblastoma has been realized after catheterization of the internal carotid and temporary balloon occlusion beyond the orifice of the ophthalmic artery, or more recently after superselective canulation of the ophthalmic artery by a microcatheter. The superselective catheterization of the ophthalmic artery could be cumbersome because of the implantation of the ostium on the carotid siphon or because of the tortuosity of the carotid siphon. We report our experience of using a retrograde approach through the posterior communicating artery that allows a more direct angle of access to the origin of the ophthalmic artery. (orig.)
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77 FR 36548 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting
2012-06-19
...) 125156 for LUCENTIS (ranibizumab) injection by Genentech, Inc., for the treatment of diabetic macular edema (DME). Ranibizumab injection is currently approved for the treatment of neovascular (wet) age-related macular degeneration (AMD) and macular edema following retinal vein occlusion (RVO). During the...
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2011-02-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Molecular and Clinical Genetics Panel of the Medical Devices Advisory...
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2010-08-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...
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Long-term results of treatment with diquafosol ophthalmic solution for aqueous-deficient dry eye.
Koh, Shizuka; Ikeda, Chikako; Takai, Yoshihiro; Watanabe, Hitoshi; Maeda, Naoyuki; Nishida, Kohji
2013-09-01
To evaluate the preliminary long-term efficacy of diquafosol ophthalmic solution for aqueous-deficient dry eye. Fifteen patients with mild-to-moderate aqueous-deficient dry eye were enrolled. After a washout period, the patients were treated with 3 % diquafosol ophthalmic solution for 6 months. We assessed 12 subjective dry eye symptoms, corneal and conjunctival staining with fluorescein, tear film break-up time (BUT), lower tear meniscus height measured with anterior-segment optical coherence tomography, Schirmer's testing, and adverse reactions at baseline and 1, 3, and 6 months after the start of treatment. Treatment with diquafosol ophthalmic solution significantly improved dry eye symptoms, corneal staining, BUT, and tear meniscus height at 1 month and maintained the effectiveness for 6 months. Conjunctival staining significantly improved 3 and 6 months after treatment. No significant adverse reactions developed. Prolonged use of diquafosol ophthalmic solution for 6 months produced significant improvement both subjectively (dry eye symptom score) and objectively (ocular staining score and tear function tests) for aqueous-deficient dry eye.
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21 CFR 349.65 - Labeling of ophthalmic emollient drug products.
2010-04-01
... product contains the established name of the drug(s), if any, and identifies the product as a “lubricant... the eye or to exposure to wind or sun.” (3) “For use as a protectant against further irritation or to...
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21 CFR 349.60 - Labeling of ophthalmic demulcent drug products.
2010-04-01
... product contains the established name of the drug(s), if any, and identifies the product as a “lubricant... exposure to wind or sun.” (3) “For use as a protectant against further irritation or to relieve dryness of...
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Regulatory and Economic Considerations of Retinal Drugs.
Shah, Ankoor R; Williams, George A
2016-01-01
The advent of anti-VEGF therapy for neovascular age-related macular degeneration and macular edema secondary to retinal vein occlusion and diabetes mellitus has prevented blindness in tens of thousands of people. However, the costs of these drugs are without precedent in ophthalmic drug therapeutics. An analysis of the financial implications of retinal drugs and the impact of the Food and Drug Administration on treatment of retinal disease must include not only an evaluation of the direct costs of the drugs and the costs associated with their administration, but also the cost savings which accrue from their clinical benefit. This chapter will discuss the financial and regulatory issues associated with retinal drugs. © 2016 S. Karger AG, Basel.
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Ophthalmic plastic and orbital surgery in Taiwan.
Hsu, Chi-Hsin; Lin, I-Chan; Shen, Yun-Dun; Hsu, Wen-Ming
2014-06-01
We describe in this paper the current status of ophthalmic plastic and orbital surgery in Taiwan. Data were collected from the Bureau of National Health Insurance of Taiwan, the Bulletin of the Taiwan Ophthalmic Plastic and Reconstructive Society, and the Statistics Yearbook of Practicing Physicians and Health Care Organizations in Taiwan by the Taiwan Medical Association. We ascertained that 94 ophthalmologists were oculoplastic surgeons and accounted for 5.8% of 1621 ophthalmologists in Taiwan. They had their fellowship training abroad (most ophthalmologists trained in the United States of America) or in Taiwan. All ophthalmologists were well trained and capable of performing major oculoplastic surgeries. The payment rates by our National Health Insurance for oculoplastic and orbital surgeries are relatively low, compared to Medicare payments in the United States. Ophthalmologists should promote the concept that oculoplastic surgeons specialize in periorbital plastic and aesthetic surgeries. However, general ophthalmologists should receive more educational courses on oculoplastic and cosmetic surgery. Copyright © 2014. Published by Elsevier B.V.
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Development and Effects of FTY720 Ophthalmic Solution on Corneal Allograft Survival
Zhaochuan Liu; Haotian Lin; Chulong Huang; Wan Chen; Wu Xiang; Yu Geng; Weirong Chen
2015-01-01
Fingolimod (FTY720), a novel class of sphingosine 1-phosphate receptor modulators, has received special interest among ophthalmologists, particularly given that oral administration of FTY720 has proven to effectively treat corneal graft rejection in animal models. However, no studies have examined the performance of FTY720 as an ophthalmic solution in reducing corneal rejection in high-risk corneal rejection models, and the stability and ocular irritation profile of FTY720 ophthalmic solution...
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Ophthalmic examination in early diagnosis of Alzheimer's disease
Directory of Open Access Journals (Sweden)
Xin Li
2018-02-01
Full Text Available Alzheimer's disease is a progressive neurodegenerative disorder causing irreversible deterioration in memory and loss of self-care ability, which is seriously affecting the quality of life. There is no cure for Alzheimer's disease. Medication only can control the progression of the disease. Early diagnosis and control of disease progress is of great significance in improving the quality of life of the patients and reducing the burden of family and society. Ophthalmic examination is seen as a window which can “see” brain directly, and some changes in the eye can reflect the changes of the brain most directly. This paper reviews the ophthalmic examination of Alzheimer's disease, including optical coherence tomography(OCT, visual field, contrast sensitivity and eye movements, et al. We hope to provide a new idea for the early diagnosis of Alzheimer's disease.
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Postoperative pain in complex ophthalmic surgical procedures: comparing practice with guidelines.
Lesin, Mladen; Sundov, Zeljka Duplancic; Jukic, Marko; Puljak, Livia
2014-06-01
To analyze the management of postoperative pain after complex ophthalmic surgery and to compare it to the guidelines. A retrospective study. University Hospital Split, Croatia. Patients (N = 447) who underwent complex ophthalmic surgical procedures from 2008 to 2012. The following data were extracted from patient medical records: age, gender, type and dosage of premedication, preoperative patient's physical status, type of procedure, duration of procedure-surgical and anesthesia time, type and dosage of anesthesia, the type and dosage of postoperative analgesia for each postoperative day. None of the patients had information about pain intensity in their records. There were 90% patients who did not receive any medication the night before surgery, 54% did not receive any premedication immediately before surgery, 19% did not receive any pain medication after the surgery in the operating room and 46% of patients did not receive any analgesics after being released to the ophthalmology department. Among those who received analgesia after surgery, 98% received only one dose of an analgesic, and 93% of patients received analgesia only on the day of the surgery. Furthermore, patients were returned to the department immediately after surgery, without intensive monitoring. During the analyzed five years there were no educational session organized by anesthesiologist to the ophthalmic surgeons. Postoperative pain management and perioperative care of patients undergoing major ophthalmic surgery indicates lack of attention towards pain intensity and postoperative analgesia. Appropriate interventions should be employed to improve postoperative pain management, to facilitate patient recovery. Wiley Periodicals, Inc.
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Ultrasound-enhanced delivery of antibiotics and anti-inflammatory drugs into the eye.
Nabili, Marjan; Patel, Hetal; Mahesh, Sankaranarayana P; Liu, Ji; Geist, Craig; Zderic, Vesna
2013-04-01
Delivery of sufficient amounts of therapeutic drugs into the eye is often a challenging task. In this study, ultrasound application (frequencies of 400 KHz to 1 MHz, intensities of 0.3-1.0 W/cm(2) and exposure duration of 5 min) was investigated to overcome the barrier properties of cornea, which is a typical route for topical administration of ophthalmic drugs. Permeability of ophthalmic drugs, tobramycin and dexamethasone and sodium fluorescein, a drug-mimicking compound, was studied in ultrasound- and sham-treated rabbit corneas in vitro using a standard diffusion cell setup. Light microscopy observations were used to determine ultrasound-induced structural changes in the cornea. For tobramycin, an increase in permeability for ultrasound- and sham-treated corneas was not statistically significant. Increase of 46%-126% and 32%-109% in corneal permeability was observed for sodium fluorescein and dexamethasone, respectively, with statistical significance (p anti-inflammatory ocular drug dexamethasone. Future investigations are needed to determine the effectiveness and safety of this application in in vivo long-term survival studies. Copyright © 2013 World Federation for Ultrasound in Medicine & Biology. Published by Elsevier Inc. All rights reserved.
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21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Fees and compensation pertaining to a color additive advisory committee. 14.155 Section 14.155 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... deposits and fees required by this section are to be paid by money order, bank draft, or certified check...
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Xu, Manlong; Sivak, Jacob G; McCanna, David J
2013-11-01
To investigate the effect of differently preserved ophthalmic solutions on the viability and barrier function of human corneal epithelial cells (HCEC) using fluorescent dyes. HCEC monolayers were exposed to the ophthalmic solutions containing benzalkonium chloride (BAK), edetate disodium, polyquad, stabilized oxychloro complex (Purite), sodium perborate, or sorbic acid for 5 min, 15 min, and 1 h. At 24 h after exposure, the cultures were assessed for metabolic activity using alamarBlue. The enzyme activity, membrane integrity, and apoptosis were evaluated using confocal microscopy. Barrier function was assessed using sodium fluorescein. The metabolic assay showed that the BAK-preserved ophthalmic solutions significantly reduced cell viability after a 5-min exposure compared to the phosphate buffered saline treated control (POphthalmic solutions with new preservatives had varying time-dependent adverse effects on cell viability, and the preservative-free solution had the least effect on HCEC. Sodium fluorescein permeability showed that HCEC monolayers treated with BAK-preserved solutions were more permeable to sodium fluorescein than those treated by the other ophthalmic solutions (Psolutions had greater adverse effects on metabolic activity, enzyme activity, membrane integrity, cell viability, and barrier function than the solutions that were not preserved with BAK. Our study suggests that BAK-free especially, preservative-free ophthalmic solutions are safer alternatives to BAK-preserved ones.
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Shortcomings of the industrial quality assurance of 106Ru ophthalmic plaques
International Nuclear Information System (INIS)
Kaulich, T.W.; Nuesslin, F.; Fluehs, D.; Haug, T.; Bamberg, M.
2001-01-01
Background: Beta emitting 106 Ru applicators manufactured by Bebig GmbH (Berlin, Germany) are widely used to treat intraocular tumors. The applicators are fixed to the bulbus and removed after several days. The following therapy relevant defects have been detected by an internal clinical acceptance test: risk of leakage and inconsistent dose-rate specifications by the manufacturer. In the meantime, components of the internal clinical acceptance test have been adopted successfully by the manufacturer of the 106 Ru ophthalmic plaques. Material and Method: 106 Ru ophthalmic plaques were tested with the following internal clinical acceptance tests: visual inspection, surface contamination, leakage, and dose-rate verification. The surface contamination test consists of a wet wipe test at moderate pressure. For the leakage test of the 106 Ru ophthalmic plaques a clinically relevant scenario was developed in which the contact of the applicator with human tissue is simulated. In the course of it the applicator is inserted into Ringer's solution for several days. The certified energy dose-rate statements of the manufacturer are examined with a 1 mm 3 plastic scintillator for consistency. (orig.) [de
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Audit of patients' awareness of ophthalmic diagnoses.
Sudesh, S; Downes, S M; McDonnell, P J
1993-09-01
Providing information to patients about their medical condition and treatment options is important in medical management. To assess patients' knowledge of their ocular disease, prognosis, and treatment a questionnaire based survey was performed. 219 patients selected by random systematic sampling during six months from patients attending general ophthalmic clinics in Selly Oak Hospital, Birmingham, were questioned and 217 questionnaires were analysed. The findings showed that patients' knowledge of their diagnosis depended on their condition: patients with common conditions such as glaucoma and cataract had a better understanding of their condition, its treatment, and prognosis compared with patients with rarer conditions such as retinal detachment or patients with multiple diagnoses. In all, 152 patients (70%) wanted more information about their condition; 49 (23%) did not (although 12 (25%) had attempted to obtain information); and 16 (7%) were undecided. In view of the few patients with a precise understanding of their ophthalmic diagnosis and prognosis and the majority's wish for access to further information, that access needs improvement and different modes of disseminating the information should be implemented.
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Pulsed UV laser technologies for ophthalmic surgery
International Nuclear Information System (INIS)
Razhev, A M; Bagayev, S N; Churkin, D S; Kargapol’tsev, E S; Chernykh, V V; Iskakov, I A; Ermakova, O V
2017-01-01
The paper provides an overview of the results of multiyear joint researches of team of collaborators of Institute of Laser Physics SB RAS together with NF IRTC “Eye Microsurgery” for the period from 1988 to the present, in which were first proposed and experimentally realized laser medical technologies for correction of refractive errors of known today as LASIK, the treatment of ophthalmic herpes and open-angle glaucoma. It is proposed to carry out operations for the correction of refractive errors the use of UV excimer KrCl laser with a wavelength of 222 nm. The same laser emission is the most suitable for the treatment of ophthalmic herpes, because it has a high clinical effect, combined with many years of absence of recrudescence. A minimally invasive technique of glaucoma operations using excimer XeCl laser (λ=308 nm) is developed. Its wavelength allows perform all stages of glaucoma operations, while the laser head itself has high stability and lifetime, will significantly reduce operating costs, compared with other types of lasers. (paper)
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Tagawa, Yoshiaki; Namba, Kenichi; Nakazono, Yumi; Iwata, Daiju; Ishida, Susumu
2017-04-01
The efficacy of epinastine 0.05% ophthalmic solution for pollen allergic conjunctivitis has already been shown in a conjunctival allergen challenge (CAC) test using cedar pollen as a challenge. The present study investigated the efficacy of this solution against birch pollen conjunctivitis in a CAC test. Ten adult subjects (eight males and two females) with asymptomatic birch pollen conjunctivitis were enrolled in this study. The average age of the subjects was 41.1 years. This study was conducted during a period without birch pollen dispersion. In each subject, the epinastine 0.05% ophthalmic solution was instilled in one eye, and an artificial tear fluid was instilled in the fellow eye in a double-blind manner. Five minutes or 4 h after the drug instillation, both eyes were challenged with an optimal concentration of birch pollen, and ocular itching and conjunctival hyperemia were then graded. Tears were collected before the drug instillation and 20 min after the pollen challenge, and the histamine level was measured. The ocular itching scores and palpebral conjunctival hyperemia scores of the epinastine-treated eyes were significantly lower than those of the contralateral control eyes when the eyes were pretreated with the drug 4 h before the CAC. There was a significant correlation between the tear histamine level and mean ocular itching score of three time points (3, 5 and 10 min) following the CAC in the control eyes but not the epinastine-treated eyes. Epinastine is effective in suppressing ocular itching and conjunctival hyperemia in birch pollen conjunctivitis. Copyright © 2017 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.
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Pediatric ophthalmic indications for examination under anesthesia in ...
African Journals Online (AJOL)
Objective: To determine the ophthalmic indications and challenges for pediatric ocular examination under anesthesia (EUA). Methods: The surgical register and patients' records of children who underwent EUA between 1990 and 2007 were examined to document patients' bio data, diagnoses and details of procedures and ...
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Chemical functionalization of hyaluronic acid for drug delivery applications
Energy Technology Data Exchange (ETDEWEB)
Vasi, Ana-Maria [“Gheorghe Asachi” Technical University of Iasi, Faculty of Chemical Engineering and Environmental Protection, 73 Prof. dr. docent Dimitrie Mangeron Street, 700050 Iasi (Romania); Popa, Marcel Ionel, E-mail: mipopa@ch.tuiasi.ro [“Gheorghe Asachi” Technical University of Iasi, Faculty of Chemical Engineering and Environmental Protection, 73 Prof. dr. docent Dimitrie Mangeron Street, 700050 Iasi (Romania); Butnaru, Maria [“Grigore T. Popa” University of Medicine Pharmacy, Faculty of Medical Bioengineering, 9-13 Kogalniceanu Street, 700454 Iasi (Romania); Dodi, Gianina [“Gheorghe Asachi” Technical University of Iasi, Faculty of Chemical Engineering and Environmental Protection, 73 Prof. dr. docent Dimitrie Mangeron Street, 700050 Iasi (Romania); SCIENT — Research Center for Instrumental Analysis, S.C. CROMATEC PLUS, 18 Sos. Cotroceni, 060114 Bucharest (Romania); Verestiuc, Liliana [“Grigore T. Popa” University of Medicine Pharmacy, Faculty of Medical Bioengineering, 9-13 Kogalniceanu Street, 700454 Iasi (Romania)
2014-05-01
Functionalized hyaluronic acid (HA) derivatives were obtained by ring opening mechanism of maleic anhydride (MA). FTIR and H{sup 1} NMR spectroscopy were used to confirm the chemical linkage of MA on the hyaluronic acid chains. Thermal analysis (TG-DTG and DSC) and GPC data for the new products revealed the formation of new functional groups, without significant changes in molecular weight and thermal stability. New gels based on hyaluronic acid modified derivatives were obtained by acrylic acid copolymerization in the presence of a redox initiation system. The resulted circular and interconnected pores of the gels were visualized by SEM. The release profiles of an ophthalmic model drug, pilocarpine from tested gels were studied in simulated media. Evaluation of the cytotoxicity and cell proliferation properties indicates the potential of the new systems to be used in contact with biological media in drug delivery applications. - Highlights: • New functionalized hyaluronic acid was prepared by ring opening of maleic anhydride. • Gels with circular pores based on acrylic acid copolymerization were formulated. • In vitro drug loading/release profile was evaluated in simulated ophthalmic media. • The cytotoxicity indicates the potential of derivatives to be used in vivo.
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A new human eye model for ophthalmic brachytherapy dosimetry
International Nuclear Information System (INIS)
Yoriyaz, H.; Sanchez, A.; Dos Santos, A.
2005-01-01
The present work proposes a new mathematical eye model for ophthalmic brachytherapy dosimetry. This new model includes detailed description of internal structures that were not treated in previous works, allowing dose determination in different regions of the eye for a more adequate clinical analysis. Dose calculations were determined with the MCNP-4C Monte Carlo particle transport code running n parallel environment using PVM. The Amersham CKA4 ophthalmic applicator has been chosen and the depth dose distribution has been determined and compared to those provide by the manufacturer. The results have shown excellent agreement. Besides, absorbed dose values due to both 125 I seeds and 60 Co plaques were obtained for each one of the different structures which compose the eye model and can give relevant information in eventual clinical analyses. (authors)
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Stability study of azithromycin in ophthalmic preparations
Directory of Open Access Journals (Sweden)
Andréia de Haro Moreno
2009-06-01
Full Text Available A stability study of azithromycin in ophthalmic preparations was developed by submission to different types of light, temperature and pH, using the biodiffusion assay (cylinder 3 x 3 for the quantifications. Bacillus subtilis, ATCC 9372, was used as test organism. The used concentration range was of 50 to 200 µg/mL. The study demonstrated that the drug suffered degradation when submitted to the ultraviolet light, germicide light, solar luminosity, acid solution, basic solution and hydrogen peroxide solution. The results were analyzed by the analysis of variance (ANOVA.O estudo de estabilidade de azitromicina em preparações oftálmicas foi realizado após exposição a diferentes tipos de luz, temperatura e pH, utilizando o método de difusão em ágar (cilindros 3 x 3 para as quantificações. A faixa de concentração foi de 50 a 200 µg/mL. O estudo demonstrou que o fármaco sofreu degradação quando submetido às luzes ultravioleta, germicida e solar, e a soluções ácida, alcalina e de peróxido de hidrogênio. Os resultados foram analisados através da análise da variância (ANOVA.
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Karpecki, Paul; Depaolis, Michael; Hunter, Judy A; White, Eric M; Rigel, Lee; Brunner, Lynne S; Usner, Dale W; Paterno, Michael R; Comstock, Timothy L
2009-03-01
Besifloxacin ophthalmic suspension 0.6% is a new topical fluoroquinolone for the treatment of bacterial conjunctivitis. Besifloxacin has potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. The primary objective of this study was to compare the clinical and microbiologic efficacy of besifloxacin ophthalmic suspension 0.6% with that of vehicle (the formulation without besifloxacin) in the treatment of bacterial conjunctivitis. This was a multicenter, prospective, randomized, double-masked, vehicle-controlled, parallel-group study in patients with acute bacterial conjunctivitis. Patients received either topical besifloxacin ophthalmic suspension or vehicle administered 3 times daily for 5 days. At study entry and on days 4 and 8 (visits 2 and 3), a clinical assessment of ocular signs and symptoms was performed in both eyes, as well as pinhole visual acuity testing, biomicroscopy, and culture of the infected eye(s). An ophthalmoscopic examination was performed at study entry and on day 8. The primary efficacy outcome measures were clinical resolution and eradication of the baseline bacterial infection on day 8 in culture-confirmed patients. The safety evaluation included adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings in all patients who received at least 1 dose of active treatment or vehicle. The safety population consisted of 269 patients (mean [SD] age, 34.2 [22.3] years; 60.2% female; 82.5% white) with acute bacterial conjunctivitis. The culture-confirmed intent-to-treat population consisted of 118 patients (60 besifloxacin ophthalmic suspension, 58 vehicle). Significantly more patients receiving besifloxacin ophthalmic suspension than vehicle had clinical resolution of the baseline infection at visit 3 (44/60 [73.3%] vs 25/58 [43.1%], respectively; P suspension compared with vehicle at visit 3 (53/60 [88.3%] vs35/58 [60.3%]; P suspension 0.6% given 3 times daily for 5 days
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Liang, Hong; Brignole-Baudouin, Françoise; Riancho, Luisa; Baudouin, Christophe
2012-01-01
The study used a validated acute in vivo model to compare a new formulation of travoprost 0.004% ophthalmic solution(travoprost PQ), preserved with polyquaternium-1 (PQ), with commercially available formulations of benzalkonium-chloride(BAK)-preserved travoprost 0.004% ophthalmic solution(travoprost BAK) and BAK-preserved latanoprost 0.005%ophthalmic solution (latanoprost BAK). Adult male New Zealand albino rabbits (n = 36) were randomly divided into 6 groups. Phosphate-buffered saline (PBS), 0.001% PQ, 0.015% BAK, travoprost PQ, travoprost BAK or latanoprost BAK were applied onto rabbit eyes as 1 drop, for 15 times at 5-min intervals.The ocular surface reactions were investigated at hour 4 and day 1 using slitlamp examination; in vivo confocal microscopy (IVCM) for cornea, limbus and conjunctiva/conjunctiva-associated lymphoid tissue, conjunctival impression cytology and standard immunohistology in cryosections for detecting CD45+ infiltrating cells and MUC-5AC-labeled cells. PBS, PQ and travoprost PQ did not induce obvious irritation by clinical observation, changes in microstructures of the whole ocular surface as measured by IVCM analysis,inflammatory infiltration or cell damage as measured by impression cytology, altered levels of goblet cell counts or numerous CD45+ cells in the cornea. In contrast, all BAK-containing products induced diffuse conjunctival hyperemia and chemosis, abnormal changes in the ocular surface microstructure,significant total ocular surface toxicity scores,damaged epithelial cells, inflammatory cell infiltration and decreased goblet cell density. Travoprost PQ did not elicitocular surface toxicity when administered to rabbit eyes.These results suggest a greater safety advantage for the ocular surface of patients receiving chronic glaucoma treatment with PQ-preserved drugs.
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Battistini, F D; Tártara, L I; Boiero, C; Guzmán, M L; Luciani-Giaccobbe, L C; Palma, S D; Allemandi, D A; Manzo, R H; Olivera, M E
2017-07-15
The aim of this work was to obtain information concerning the properties of ophthalmic formulations based on hyaluronic-drug ionic complexes, to identify the factors that determine the onset, intensity and duration of the pharmacotherapeutic effect. Dispersions of a complex of 0.5% w/v of sodium hyaluronate (HyNa) loaded with 0.5% w/v of timolol maleate (TM) were obtained and presented a counterionic condensation higher than 75%. For comparison a similar complex obtained with hyaluronic acid (HyH) was also prepared. Although the viscosity of HyNa-TM was significantly higher than that of HyH-TM, in vitro release of TM from both complexes showed a similar extended drug release profile (20-31% over 5h) controlled by diffusion and ionic exchange. Ocular pharmacokinetic study performed in normotensive rabbits showed that HyNa-TM complex exhibited attractive bioavailability properties in the aqueous humor (AUC and Cmax significantly higher and later Tmax) compared to commercial TM eye-drops. Moreover, a more prolonged period of lowered intra-ocular pressure (10h) and a more intense hypotensive activity was observed after instillation of a drop of HyNa-TM as compared to the eye-drops. Such behavior was related to the longer pre-corneal residence times (400%) observed with HyNa-TM complex. No significant changes in rabbit transcorneal permeation were detected upon complexation. These results demonstrate that the ability of HyNa to modulate TM release, together with its mucoadhesiveness related to the viscosity, affected both the pharmacokinetic and pharmacodynamic parameters. The HyNa-TM complex is a potentially useful carrier for ocular drug delivery, which could improve the TM efficacy and reduce the frequency of administration to improve patient compliance. Copyright © 2017 Elsevier B.V. All rights reserved.
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Ayaki, Masahiko; Yaguchi, Shigeo; Iwasawa, Atsuo; Koide, Ryohei
2008-08-01
The cytotoxicity of a range of commercial ophthalmic solutions in the presence and absence of preservatives was assessed in human corneal endothelial cells (HCECs), corneal epithelia and conjunctival epithelia using in vitro techniques. Cell survival was measured using the WST-1 assay for endothelial cells and the MTT assay for epithelial cells. Commercially available timolol, carteolol, cromoglicate, diclofenac, bromfenac and hyaluronic acid ophthalmic solutions were assessed for cytotoxicity in the presence and absence of preservatives. The preservatives benzalkonium, chlorobutanol and polysorbate were also tested. The survival of cells exposed to test ophthalmic solutions was expressed as a percentage of cell survival in the control solution (distilled water added to media) after 48 h exposure. HCEC survival was 20-30% in ophthalmic solutions diluted 10-fold. The survival of HCEC was significantly greater in all solutions in the absence of preservative than in the presence of preservative. The survival of corneal and conjunctival epithelia was consistent with that of HCECs for all test ophthalmic solutions. The preservatives polysorbate and benzalkonium were highly cytotoxic with cell survival decreasing to 20% at the concentration estimated in commercial ophthalmic solutions. By comparison, the survival of cells exposed to chlorobutanol was 80% or greater. The cytotoxicity of ophthalmic solutions to HCEC, corneal epithelia and conjunctival epithelia decreased in the absence of preservative.
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Novel liquid application systems for poorly soluble drugs
Luschmann, Christoph Roman
2015-01-01
This thesis was focused on the development of efficient novel liquid formulations for poorly water soluble drugs for the treatment of inflammatory ophthalmic diseases. With Restasis® there is currently only one drug product approved by the FDA, in the US only, for the treatment of dry eye syndrome. It still suffers from low bioavailability, bad biocompatibility and thus a low patient compliance, as well as cumbersome manufacturing. Hence, there is a tremendous lack in the options for a causal...
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75 FR 43156 - Federal Advisory Committee; Missile Defense Advisory Committee
2010-07-23
... DEPARTMENT OF DEFENSE Office of the Secretary Federal Advisory Committee; Missile Defense Advisory Committee AGENCY: Missile Defense Agency (MDA), DoD. ACTION: Notice of closed meeting. SUMMARY: Under the... Defense announces that the Missile Defense Advisory Committee will meet on August 4 and 5, 2010, in...
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Khoh-Reiter, Su; Jessen, Bart A
2009-07-28
Benzalkonium chloride (BAC) is a common preservative used in ophthalmic solutions. The aim of this study was to compare the cytotoxic effects of BAC-containing ophthalmic solutions with a BAC-free ophthalmic solution using an organotypic 3-dimensional (3-D) corneal epithelial model and to determine the effects of latanoprost ophthalmic solution and its BAC-containing vehicle on corneal thickness in a monkey model. The cytotoxicity of commercially available BAC-containing ophthalmic formulations of latanoprost (0.02% BAC) and olopatadine (0.01% BAC) was compared to that of BAC-free travoprost and saline in a corneal organotypic 3-D model using incubation times of 10 and 25 minutes. To compare the extent of differentiation of 3-D corneal cultures to monolayer transformed human corneal epithelial (HCE-T) cell cultures, expression levels (mRNA and protein) of the corneal markers epidermal growth factor receptor, transglutaminase 1 and involucrin were quantified. Finally, latanoprost ophthalmic solution or its vehicle was administered at suprapharmacologic doses (two 30 microL drops twice daily in 1 eye for 1 year) in monkey eyes, and corneal pachymetry was performed at baseline and at weeks 4, 13, 26 and 52. In the 3-D corneal epithelial culture assays, there were no significant differences in cytotoxicity between the BAC-containing latanoprost and olopatadine ophthalmic solutions and BAC-free travoprost ophthalmic solution at either the 10- or 25-minute time points. The 3-D cultures expressed higher levels of corneal epithelial markers than the HCE-T monolayers, indicating a greater degree of differentiation. There were no significant differences between the corneal thickness of monkey eyes treated with latanoprost ophthalmic solution or its vehicle (both containing 0.02% BAC) and untreated eyes. The lack of cytotoxicity demonstrated in 3-D corneal cultures and in monkey studies suggests that the levels of BAC contained in ophthalmic solutions are not likely to cause
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Directory of Open Access Journals (Sweden)
Jessen Bart A
2009-07-01
Full Text Available Abstract Background Benzalkonium chloride (BAC is a common preservative used in ophthalmic solutions. The aim of this study was to compare the cytotoxic effects of BAC-containing ophthalmic solutions with a BAC-free ophthalmic solution using an organotypic 3-dimensional (3-D corneal epithelial model and to determine the effects of latanoprost ophthalmic solution and its BAC-containing vehicle on corneal thickness in a monkey model. Methods The cytotoxicity of commercially available BAC-containing ophthalmic formulations of latanoprost (0.02% BAC and olopatadine (0.01% BAC was compared to that of BAC-free travoprost and saline in a corneal organotypic 3-D model using incubation times of 10 and 25 minutes. To compare the extent of differentiation of 3-D corneal cultures to monolayer transformed human corneal epithelial (HCE-T cell cultures, expression levels (mRNA and protein of the corneal markers epidermal growth factor receptor, transglutaminase 1 and involucrin were quantified. Finally, latanoprost ophthalmic solution or its vehicle was administered at suprapharmacologic doses (two 30 μL drops twice daily in 1 eye for 1 year in monkey eyes, and corneal pachymetry was performed at baseline and at weeks 4, 13, 26 and 52. Results In the 3-D corneal epithelial culture assays, there were no significant differences in cytotoxicity between the BAC-containing latanoprost and olopatadine ophthalmic solutions and BAC-free travoprost ophthalmic solution at either the 10- or 25-minute time points. The 3-D cultures expressed higher levels of corneal epithelial markers than the HCE-T monolayers, indicating a greater degree of differentiation. There were no significant differences between the corneal thickness of monkey eyes treated with latanoprost ophthalmic solution or its vehicle (both containing 0.02% BAC and untreated eyes. Conclusion The lack of cytotoxicity demonstrated in 3-D corneal cultures and in monkey studies suggests that the levels of BAC
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Takamura, Etsuko; Tsubota, Kazuo; Watanabe, Hitoshi; Ohashi, Yuichi
2012-10-01
To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in dry eye patients, using mean changes in fluorescein and rose bengal staining scores as endpoints. TRIAL DESIGN AND METHODS: In this multicenter, randomised, double-masked, parallel study of 286 dry eye patients with fluorescein and rose bengal staining scores of ≥3 were randomised to the treatment groups in a 1 : 1 ratio. Efficacy and safety were evaluated after drop-wise instillation of the study drug, six times daily for 4 weeks. After 4 weeks, the intergroup difference in the mean change from baseline in fluorescein staining score was -0.03; this verified the non-inferiority of diquafosol. The mean change from baseline in rose bengal staining score was significantly lower in the diquafosol group (p=0.010), thus verifying its superiority. The incidence of adverse events was 26.4% and 18.9% in the diquafosol and sodium hyaluronate groups, respectively, with no significant difference. Diquafosol (3%) and sodium hyaluronate (0.1%) exhibit similar efficacy in improving fluorescein staining scores of dry eye patients, whereas, diquafosol exhibits superior efficacy in improving rose bengal staining scores. Diquafosol has high clinical efficacy and is well tolerated with a good safety profile.
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Doppler sonographic evaluation of ophthalmic arterial flow pattern in hypertensive patients
International Nuclear Information System (INIS)
Ryu, Dae Sik; Kim, Young Goo
1994-01-01
To compare the Doppler velocity waveform pattern of ophthalmic artery of hypertensive patients with that of normotensive subjects. Doppler velocity waveform was obtained from ophthalmic artery in 45 hypertensive patients and 60 normotensive subjects. Both hypertensives and normotensive subjects were classified according to age into those younger than and those older than 45 years. Doppler indices(pulsatility index(PI), resistance index(RI), the first systolic peak/the second systolic peak(S1/S2), the first systolic peak/diastolic peak(S1/D)) measured in hypertensive patients were compared with normotensive subjects. Among the various doppler indices, only S1/S2 showed significant difference(P < 0.05) between the hypertensive patients and normotensive subjects younger than 45 years. Doppler velocity waveform of hypertensive patients older than 45 years showed no significant difference from that of normotensive subjects with corresponding age. Doppler velocity waveform of ophthalmic artery in hypertensive patients younger than 45 years shows pattern with S2 higher than that of normotensive subjects. High S2 component(reflective-wave) may represent increased vascular impedance due to vasococonstriction of retinal arterioles in hypertensive patients
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Rojanarata, Theerasak; Tankul, Junlathip; Woranaipinich, Chayanee; Potawanich, Paweena; Plianwong, Samarwadee; Sakulma, Sirinart; Saehuan, Choedchai
2010-10-01
The aim of this study was to investigate the stability of fortified cefazolin sodium ophthalmic solutions (50 mg mL⁻¹) extemporaneously prepared in commercial artificial tears containing 2 different types of preservatives, namely the surfactants and oxidants. Fortified cefazolin sodium solutions were prepared by reconstituting cefazolin for injection with sterile water and further diluted with Tears Naturale II or Natear, 2 commercial artificial tears containing polyquaternium-1 and sodium perborate, respectively, as preservatives. The solutions were then kept at room temperature (28°C) or in the refrigerator (4°C). During the 28-day period, the formulations were periodically examined for the physical appearance, pH, and the remaining drug concentrations. The antibacterial potency was evaluated as the minimal inhibitory concentration against Staphylococcus aureus strain ATCC 29923 by broth dilution technique. The activity of the preservatives was demonstrated by antimicrobial effectiveness tests. On day 28, the microbial contamination in the preparations was tested. The stability profiles of cefazolin solutions prepared in Tears Naturale II, Natear, and water were not different, but they were significantly influenced by the storage temperature. The refrigerated formulations showed no loss of drug and antibacterial potency as well as alteration of physical appearance and pH throughout the 28 days. In contrast, those kept at room temperature showed gradual change in color and odor. The degradation of drug exceeded 10% from day 3 and the decrease of antibacterial potency could be observed at week 3. All cefazolin solutions prepared in artificial tears retained the antimicrobial activity of preservatives and were free from bacterial and fungal contamination throughout the 28-day period of study. Cefazolin sodium ophthalmic solutions can be extemporaneously prepared in Tears Naturale II or Natear without the influence from different types of preservatives used in
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2011-03-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...
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New Zealand health reforms: effect on ophthalmic practice.
Raynel, S; Reynolds, H
1999-01-01
Are specialized ophthalmic units with inpatient facilities going to disappear in the New Zealand public health system? We have entered the era of cost containment, business methodologies, bench marking, day case surgery, and technologic advances. The dilemma for nursing is maintenance of a skill base with dwindling clinical practice areas.
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Effect of topical ophthalmic epinastine and olopatadine on tear volume in mice.
Villareal, Arturo L; Farley, William; Pflugfelder, Stephen C
2006-12-01
To investigate the effects of topical epinastine and olopatadine on tear volume by using a mouse model. Eighty-five C57BL6 mice (170 eyes) were treated twice daily with topical ophthalmic epinastine 0.05%, olopatadine 0.1%, or atropine 1% or served as untreated controls. A thread-wetting assay was used to measure tear volume at baseline and 15, 45, 90, 120, and 240 minutes after the last instillation of the drug on days 2 and 4 of treatment. After 2 days of treatment, epinastine-treated mice showed greater mean tear volumes than olopatadine-treated mice did at 15, 45, 90, and 240 minutes, with statistical significance at 15 and 45 minutes (Placrimal functional unit, epinastine may be an especially good choice for the treatment of allergic conjunctivitis in patients with dry eye disease or in those who are at risk for developing dry eye.
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78 FR 64956 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
2013-10-30
... treatment of metabolic disorders associated with lipodystrophy, including diabetes mellitus and/or... than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a... 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee...
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Ophthalmic Morbidity in School Children in Hilly Areas of Uttarakhand
Directory of Open Access Journals (Sweden)
Surekha Kishore
2014-03-01
Full Text Available Introduction: School children constitute about one fourth of population of India. Early detection and treatment of various eye diseases helps in avoiding many complications. The magnitude of blindness is 3-4 times greater in developing countries. Very few studies have been conducted in Uttarakhand revealing the ophthalmic morbidity in school children or general population. Hilly areas especially the remote ones face various problems like, poor transportation facilities, distant health facilities, use of traditional methods for treatment, faith healing, customs and belief system, lack of information. Moreover water supply, poor personal hygiene and other factors also add up to these problems. Aim: To study the ophthalmic morbidities in school children in 3 schools of Thatyur block. Methodology: It was a cross sectional study. Result: A total of 705 students were enrolled. Permission from school authorities was seeked before the start of study. Schools were visited twice in a week current and preliminary information was taken from the students & teacher regarding education, occupation, income etc. General examination and ophthalmic examination was done with day & torch light along with refraction, with the help of standard Snellen’s chart. Each eye was examined separately. A vision of 6/6 was considered as normal. Near vision was tested with new vision Snellen’s chart at 12-14 inches away from eye.
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Ophthalmic Morbidity in School Children in Hilly Areas of Uttarakhand
Directory of Open Access Journals (Sweden)
Surekha Kishore
2014-03-01
Full Text Available Introduction: School children constitute about one fourth of population of India. Early detection and treatment of various eye diseases helps in avoiding many complications. The magnitude of blindness is 3-4 times greater in developing countries. Very few studies have been conducted in Uttarakhand revealing the ophthalmic morbidity in school children or general population. Hilly areas especially the remote ones face various problems like, poor transportation facilities, distant health facilities, use of traditional methods for treatment, faith healing, customs and belief system, lack of information. Moreover water supply, poor personal hygiene and other factors also add up to these problems. Aim: To study the ophthalmic morbidities in school children in 3 schools of Thatyur block. Methodology: It was a cross sectional study. Result: A total of 705 students were enrolled. Permission from school authorities was seeked before the start of study. Schools were visited twice in a week current and preliminary information was taken from the students & teacher regarding education, occupation, income etc. General examination and ophthalmic examination was done with day & torch light along with refraction, with the help of standard Snellen’s chart. Each eye was examined separately. A vision of 6/6 was considered as normal. Near vision was tested with new vision Snellen’s chart at 12-14 inches away from eye.
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Koekoek, Clarence G. J.; Meiners, Linda C.; Pott, Jan Willem R.
The aim of the study is to report the frequency of missed diagnoses on magnetic resonance and computerised tomographic imaging in neuro-ophthalmic patients who were referred to an academic ophthalmology department, with apparent normal imaging. The authors included all neuro-ophthalmic patients,
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Narainsamy, Kinsley; Farci, Sandrine; Braun, Emilie; Junot, Christophe; Cassier-Chauvat, Corinne; Chauvat, Franck
2016-04-01
Using genetics and metabolomics we investigated the synthesis (gshA and gshB genes) and catabolism (ggt) of the conserved antioxidant glutathione in the model cyanobacterium Synechocystis PCC6803. These three genes are crucial to Synechocystis, in agreement with the proposed invention of glutathione by ancient cyanobacteria to protect themselves against the toxicity of oxygen they produced through photosynthesis. Consistent with their indispensability, gshA and gshB also operate in the production of another antioxidant, ergothioneine, as well as of the glutathione analogues ophthalmate and norophthalmate. Furthermore, we show that glutathione, ophthalmate and norophthalmate are accumulated in cells stressed by glucose, and that the two glutathione-dependent glyoxalase enzymes operate in the protection against glucose and its catabolite methylglyoxal. These findings are interesting because ophthalmate and norophthalmate were observed only in mammals so far, where ophthalmate is regarded as a biomarker of glutathione depletion. Instead, our data suggest that ophthalmate and norophthalmate are stress-induced markers of cysteine depletion triggered by its accelerated incorporation into glutathione, to face its increased demand for detoxification purposes. Hence, Synechocystis is an attractive model for the analysis of the role of glutathione, ergothioneine, ophthalmate and norophthalmate, in signalling and detoxification of oxidants and metabolic by-products. © 2015 John Wiley & Sons Ltd.
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2011-03-18
... Alcohol Abuse and Alcoholism; National Institute on Drug Abuse; Notice of Meeting Pursuant to section 10(a... meeting of the National Advisory Council on Alcohol Abuse and Alcoholism and the National Advisory Council on Drug Abuse. The meeting will be open to the public, with attendance limited to space available...
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Full Text Available ... Meetings & Events Media Guide About NIDA Director's Page Organization Legislative Activities Advisory Boards & Groups Working at NIDA Donating to ... 2005 –Ongoing Behaviors associated with drug misuse are among the main ...
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Ophthalmic manifestations of head injury.
Kowal, L
1992-02-01
Head injuries are frequently associated with ophthalmic problems. The commonest problems seen in this series of 161 patients with head injury were problems with poor accommodation (16% of patients; 58% of these persisted), convergence (14% of patients; 35% of these persisted), pseudomyopia (19%; 55% persisted) and optic atrophy (26% of the patients; 78% of these were mild and easily missed on routine testing, and 22% were severe). Motility disorders were common, especially cranial nerve palsies. Other less frequent motility disturbances included apparent inferior oblique palsy, comitant esotropia, and exotropia which was often of the convergence insufficiency type.
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Chitosan/alginate based multilayers to control drug release fromophthalmic lens
Silva, Diana; Pinto, Luís F. V.; Bozukova, Dimitriya; Santos, Luís F.; Serro, Ana Paula; Saramago, Benilde
2016-01-01
In this study we investigated the possibility of using layer-by-layer deposition, based in natural polymers (chitosan and alginate), to control the release of different ophthalmic drugs from three types of lens materials: a silicone-based hydrogel recently proposed by our group as drug releasing soft contact lens (SCL) material and two commercially available materials: CI26Y for intraocular lens (IOLs) and Definitive 50 for SCLs. The optimised coating, consisting in one double layer of (algin...
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Tofflemire, Kyle L; Whitley, Elizabeth M; Flinn, Allison M; Dufour, Valerie L; Ben-Shlomo, Gil; Allbaugh, Rachel A; Griggs, Angela N; Peterson, Chimene S; Whitley, David R
2015-11-01
To compare the effect of commercially available solution and compounded ointment formulations of dorzolamide(2%)-timolol(0.5%) on intraocular pressure (IOP) of normal horses. Eighteen clinically normal horses. A randomized, masked prospective design was used with horses divided into two equal groups. One eye of each horse was selected for topical ophthalmic treatment with either 0.2 mL of dorzolamide(2%)-timolol(0.5%) solution or 0.2 g of dorzolamide(2%)-timolol(0.5%) ointment every 12 h for 5 days. The contralateral eye of horses in both groups was untreated. Rebound tonometry was performed every 6 h starting 2 days prior to and ending 2 days after the treatment period. The mean IOP reduction in eyes treated with the solution or ointment formulations was 13%. Untreated eyes in both groups experienced a lesser but still statistically significant reduction in IOP. The IOP values did not return to baseline within 48 h of the last treatment. The commercially available solution and compounded ointment formulations of ophthalmic dorzolamide(2%)-timolol(0.5%) had similar effects on IOP in normal horses. Persistent IOP reduction following cessation of treatment may indicate prolonged drug effect or acclimation of horses to tonometry. © 2014 American College of Veterinary Ophthalmologists.
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75 FR 36373 - Federal Advisory Committee; Advisory Council on Dependents' Education
2010-06-25
..., the Department of Defense announces that the Advisory Council on Dependents' Education will meet on... response to the stated agenda of the planned meeting of the Advisory Council on Dependents' Education. All... membership for their consideration. For the next meeting of the Advisory Council on Dependents' Education, Dr...
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75 FR 22146 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting
2010-04-27
... of the treatment of hypoactive sexual desire disorder in premenopausal women. FDA intends to make... public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public... least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory...
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21 CFR 14.22 - Meetings of an advisory committee.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Meetings of an advisory committee. 14.22 Section... of, and with an agenda approved by, the designated Federal employee or alternate. No meeting may be held in the absence of the designated Federal employee. (1) If any matter is added to the agenda after...
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Cho, Hyung; Wolf, Kenneth J; Wolf, Eric J
2009-01-01
Hyung Cho1, Kenneth J Wolf1, Eric J Wolf21Department of Ophthalmology, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, USA; 2Department of Ophthalmology, Edward S. Harkness Eye Institute of Columbia University College of Physicians and Surgeons, New York, NY, USAAbstract: Recently, several new ophthalmic NSAID products have been introduced for commercial use in the United States. The purpose of this review is to briefly overview the ophthalmic NSAIDs currently...
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75 FR 22757 - Federal Advisory Committee; Army Education Advisory Committee; Charter Renewal
2010-04-30
..., school curriculums, educational philosophy and objectives, program effectiveness, facilities, staff and... DEPARTMENT OF DEFENSE Office of the Secretary Federal Advisory Committee; Army Education Advisory... Defense gives notice that it is renewing the charter for the Army Education Advisory Committee (hereafter...
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Longitudinal ophthalmic findings in a child with Helsmoortel-Van der Aa Syndrome
Directory of Open Access Journals (Sweden)
Michael J. Gale
2018-06-01
Full Text Available Purpose: We present the first detailed ophthalmic description of a child with Helsmoortel-Van der Aa Syndrome (HVDAS, including longitudinal follow-up and analysis. Observations: After extensive workup, a young child with poor visual behavior, hypotonic cerebral palsy, intellectual disability, and global developmental delay was found to have a heterozygous de novo mutation in the ADNP gene and diagnosed with HVDAS. Ophthalmic findings were remarkable for progressive nystagmus, macular pigment mottling, mild foveal hypoplasia with abnormal macular laminations, persistent rod dysfunction with electronegative waveform, and progressive cone degeneration. Conclusions and importance: Patients with HVDAS are known to have abnormal visual behavior due to refractive or cortical impairment. However, we present the first description, to our knowledge, of an association with retinal mal-development and degeneration. Thus, patients with HVDAS should be referred for ophthalmic genetics evaluation, and HVDAS should be on the differential diagnosis for young children with global developmental delay who present with nystagmus, rod and cone dysfunction with electronegative waveform, and relative lack of severe structural degeneration on optical coherence tomography. Keywords: Helsmoortel-Van der Aa Syndrome, HVDAS, Activity-dependent neuroprotective protein, ADNP, Nystagmus, Retinal degeneration, Electronegative waveform, Optical coherence tomography
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75 FR 51985 - Federal Advisory Committee; Advisory Council on Dependents' Education (ACDE)
2010-08-24
... Advisory Council on Dependents' Education (ACDE) scheduled for September 8, 2010, is cancelled. The meeting... submit written statements to the Advisory Council on Dependents' Education about its mission and... planned meeting of the Advisory Council on Dependents' Education. All written statements shall be...
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Wiggans, K Tomo; Sanchez-Migallon Guzman, David; Reilly, Christopher M; Vergneau-Grosset, Claire; Kass, Philip H; Hollingsworth, Steven R
2018-02-01
OBJECTIVE To describe diagnosis, treatment, and outcome of and risk factors for ophthalmic disease in leopard geckos (Eublepharis macularius) evaluated at a veterinary teaching hospital. DESIGN Retrospective case series. ANIMALS 112 of 144 (78%) leopard geckos that were evaluated at a veterinary teaching hospital in January 1985 through October 2013 and for which sufficient medical record information was available. PROCEDURES Information from medical records was used to identify leopard geckos with ophthalmic disease, characterize cases, and determine risk factors for the presence of ophthalmic disease. RESULTS Of the 112 leopard geckos, 52 (46%) had ophthalmic disease (mainly corneal or conjunctival disease). Female geckos were less likely to have ophthalmic disease, and there was a positive association between increasing age and ophthalmic disease. Use of a paper towel substrate, absence of any heat source, and lack of vitamin A supplementation were positively associated with a diagnosis of ophthalmic disease. Head dysecdysis was the only concurrent disorder significantly associated with ophthalmic disease. At necropsy, 5 affected leopard geckos had squamous metaplasia of the conjunctivae. CONCLUSIONS AND CLINICAL RELEVANCE Results indicated that ophthalmic disease is a common finding in leopard geckos. The cause of ocular surface disease in leopard geckos may be multifactorial, and hypovitaminosis A may be an important risk factor. Although animals receiving supplemental vitamin A were less likely to have ophthalmic disease, further understanding is required regarding the metabolism of and nutritional requirements for vitamin A in leopard geckos.
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Saleh, George M; Lamparter, Julia; Sullivan, Paul M; O'Sullivan, Fiona; Hussain, Badrul; Athanasiadis, Ioannis; Litwin, Andre S; Gillan, Stewart N
2013-06-01
To investigate the effect of a structured, supervised, cataract simulation programme on ophthalmic surgeons in their first year of training, and to evaluate the level of skill transfer. Trainees with minimal intraocular and simulator experience in their first year of ophthalmology undertook a structured, sequential, customised, virtual reality (VR) cataract training programme developed through the International Forum of Ophthalmic Simulation. A set of one-handed, bimanual, static and dynamic tasks were evaluated before and after the course and scores obtained. Statistical significance was evaluated with the Wilcoxon sign-rank test. The median precourse score of 101.50/400 (IQR 58.75-145.75) was significantly improved after completing the training programme ((postcourse score: 302/400, range: 266.25-343), p<0.001). While improvement was evident and found to be statistically significant in all parameters, greatest improvements were found for capsulorhexis and antitremor training ((Capsulorhexis: precourse score=0/100, range 0-4.5; postcourse score=81/100, range 13-87.75; p=0.002), (antitremor training: precourse score=0/100, range 0-0; postcourse score=80/100, range 60.25-91.50; p=0.001)). Structured and supervised VR training can offer a significant level of skills transfer to novice ophthalmic surgeons. VR training at the earliest stage of ophthalmic surgical training may, therefore, be of benefit.
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Creation of nano eye-drops and effective drug delivery to the interior of the eye
Ikuta, Yoshikazu; Aoyagi, Shigenobu; Tanaka, Yuji; Sato, Kota; Inada, Satoshi; Koseki, Yoshitaka; Onodera, Tsunenobu; Oikawa, Hidetoshi; Kasai, Hitoshi
2017-03-01
Nano eye-drops are a new type of ophthalmic treatment with increased potency and reduced side effects. Compounds in conventional eye-drops barely penetrate into the eye because the cornea, located at the surface of eye, has a strong barrier function for preventing invasion of hydrophilic or large-sized materials from the outside. In this work, we describe the utility of nano eye-drops utilising brinzolamide, a commercially available glaucoma treatment drug, as a target compound. Fabrication of the nanoparticles of brinzolamide prodrug increases the eye penetration rate and results in high drug efficacy, compared with that of commercially available brinzolamide eye-drops formulated as micro-sized structures. In addition, the resulting nano eye-drops were not toxic to the corneal epithelium after repeated administration for 1 week. The nano eye-drops may have applications as a next-generation ophthalmic treatment.
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Wang, Jiantao; Kan, Zhisheng; Wang, Shuo
2017-01-01
Abstract Background: The clipping of multiple intracranial aneurysms in 1 stage is uncommon. In this case, we report clipping of an ophthalmic aneurysm associated with multiple anterior and posterior circulation aneurysms via the Dolenc approach. Methods: The main symptoms of the patient are headache, along with nausea and vomiting. The patient's arteriogram revealed a wide-necked aneurysm of the right ophthalmic artery, an irregular aneurysm of the anterior communicating artery, and a basilar artery aneurysm. The surgical intervention for these aneurysms is a challenge because of the complex anatomical relationship with the surrounding structures. The 3 aneurysms, which were not amenable to a single intervention, were successfully clipped in 1 incision. Results: After surgery, the patient reported feeling well. One year after surgery, the patient had no SAH recurrence. Conclusions: Occasionally, surgical treatment was used even for aneurysms of the carotid-ophthalmic artery with aneurysms of anterior communicating artery and basilar artery, which are contraindicated for interventional therapy. PMID:28422878
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2011-05-23
... Management, for the purpose of identifying leading business practices that have the potential to improve...'s Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting AGENCY: Office...: The President's Management Advisory Board, a Federal Advisory Committee established in accordance with...
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Asada, Hiroyuki; Takaoka-Shichijo, Yuko; Nakamura, Masatsugu; Kimura, Akio
2010-06-01
Optimization of benzalkonium chloride (alkyl dimethylbenzylammonium chloride: BAK) concentration as preservative in 0.0015% tafluprost ophthalmic solution (Tapros 0.0015% ophthalmic solution), an anti-glaucoma medicine, was examined from the points of ocular surface safety and preservative efficacy. BAKC(12), which is dodecyl dimethylbenzylammonium chloride, and BAKmix, which is the mixture of dodecyl, tetradecyl and hexadecyl dimethylbenzylammonium chloride were used in this study. The effects of BAKC(12) concentrations and the BAK types, BAKC(12) and BAKmix, in tafluprost ophthalmic solution on ocular surface safety were evaluated using the in vitro SV 40-immobilized human corneal epithelium cell line (HCE-T). Following treatments of Tafluprost ophthalmic solutions with BAKC(12), its concentration dependency was observed on cell viability of HCE-T. The cell viability of HCE-T after treatment of these solutions with 0.001% to 0.003% BAKC(12) for 5 minutes were the same level as that after treatment of the solution without BAK. Tafluprost ophthalmic solution with 0.01% BAKC(12) was safer for the ocular surface than the same solution with 0.01% BAKmix. Preservatives-effectiveness tests of tafluprost ophthalmic solutions with various concentrations of BAKC(12) were performed according to the Japanese Pharmacopoeia (JP), and solutions with more than 0.0005% BAKC(12) conformed to JP criteria. It was concluded that 0.0005% to 0.003% of BAKC(12) in tafluprost ophthalmic solution was optimal, namely, well-balanced from the points of ocular surface safety and preservative efficacy.
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21 CFR 524.390d - Chloramphenicol-prednisolone ophthalmic ointment.
2010-04-01
.... 017030 in § 510.600(c) of this chapter. (c) Conditions of use. Dogs and cats—(1) Amount. Apply 4 to 6...) Limitations. Therapy for cats should not exceed 7 days, prolonged use in cats may produce blood dyscrasia. As... institute appropriate therapy. All topical ophthalmic preparations containing corticosteroids, with or...
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The Use of Flow Diverting Stents to Treat Para-Ophthalmic Aneurysms
Directory of Open Access Journals (Sweden)
Pervinder Bhogal
2017-08-01
Full Text Available Background and purposeFew publications have dealt exclusively with the use of flow diverter stents for the treatment of para-ophthalmic aneurysms. We sought to determine the efficacy of flow diverting stents (FDSs to treat aneurysms in this specific location.MethodsWe retrospectively reviewed our database of prospectively collected information for all patients treated with flow diversion for an unruptured saccular para-ophthalmic aneurysm between September 2009 and January 2016. The aneurysm fundus size, neck size, number and type of FDS, complications, and follow-up data were recorded.ResultsWe identified 74 patients that matched our inclusion criteria. Of these patients, 18 patients were male (24.3%. The average fundus size was 4.8 mm, 11 aneurysms had previous coil occlusions and 63 were treated solely with flow diversion. At an initial angiographic follow-up (mean avg. 3.2 months, 71.8% of the aneurysms were occluded, and at the last follow-up (mean avg. 31.8 months, 88.9% of aneurysms were occluded. One patient suffered permanent morbidity (1.36% secondary to interruption of the antiplatelet medication and another died (1.36% secondary to in-stent thrombosis that was also due to an interruption in the antiplatelet medication.ConclusionTreatment of saccular para-ophthalmic aneurysms with FDS is feasible and carries a high degree of technical success with low complication rates and excellent rates of aneurysm exclusion.
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Ophthalmic epidemiology in Europe
DEFF Research Database (Denmark)
Delcourt, Cécile; Korobelnik, Jean-François; Buitendijk, Gabriëlle H S
2016-01-01
The European Eye Epidemiology (E3) consortium is a recently formed consortium of 29 groups from 12 European countries. It already comprises 21 population-based studies and 20 other studies (case-control, cases only, randomized trials), providing ophthalmological data on approximately 170,000 Euro......The European Eye Epidemiology (E3) consortium is a recently formed consortium of 29 groups from 12 European countries. It already comprises 21 population-based studies and 20 other studies (case-control, cases only, randomized trials), providing ophthalmological data on approximately 170......,000 European participants. The aim of the consortium is to promote and sustain collaboration and sharing of data and knowledge in the field of ophthalmic epidemiology in Europe, with particular focus on the harmonization of methods for future research, estimation and projection of frequency and impact...
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Long-term ophthalmic health care in Usher syndrome type I from an ICF perspective.
Möller, Kerstin; Eriksson, Kristina; Sadeghi, André M; Möller, Claes; Danermark, Berth
2009-01-01
The aim was to explore ophthalmic health care in female patients with Usher Syndrome type I (USH I) over 20 years and to evaluate the relationship between the ophthalmic health care and the health state of the patients from a health perspective. A retrospective study of records from ophthalmology departments (OD) and low vision clinics (LVC) from 1985 to 2004. Assessment of the reports was performed based on the International Classification of Functioning, Disability and Health (ICF). Findings were analysed by manifest content analysis with ICF as a framework and using four themes: health care system, procedure examinations, patient's functioning and disability and procedure actions. The records of nine female patients (aged 25-39 years, 1985) with USH I were selected from the national database of USH. A great number of notes were collected (OD 344 and LVC 566). Procedure examinations were exclusively oriented towards body structure and function. All patients showed aggravated visual impairment over and above the hearing and vestibular impairment. Procedure actions were oriented towards environmental factors. No correlation was found between procedures performed and patient's experience of disability. The high degree of resource allocation was not correlated to the patients' impairment. The study indicates that the ophthalmic health care was characterised by inefficiency. This conclusion is very serious because patients very likely face severe disability and emotional difficulties. ICF is ought to be incorporated in ophthalmic health care strategy to improve the health care.
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Macrì, Angelo; Vagge, Aldo; Salis, Annalisa; Fucile, Carmen; Marini, Valeria; Martelli, Antonietta; Giuffrida, Sebastiano; Iester, Michele; Damonte, Gianluca; Mattioli, Francesca
2017-04-01
The purpose of this study was to evaluate the aqueous humor concentrations of bromfenac ophthalmic solution 0.09 % in patients undergoing phacoemulsification. Patients requiring cataract extraction received one drop (50 µL) of bromfenac 0.09 % solution in the eye to be operated, before bedtime the day before surgery or the morning of the surgery. The last administration was recorded. At the time of paracentesis, an aqueous humor sample was collected with a 30-gauge needle attached to a TB syringe and was later analyzed by high-performance liquid chromatography for drug concentration. 188 treated volunteers and 48 control, untreated, subjects were included in the study. The mean aqueous concentration of bromfenac in the treated group was 37.60 ± 68.86 and 0 nM (nmol/L) in the control group (p < 0.0001). Correlation coefficient in bromfenac group between time elapsed from instillation and drug concentration was -0.16 (p not significant). Bromfenac showed properties of good penetration and stable concentration in aqueous humor up to about 12 h after instillation.
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Hsu, Kuan-Hui; Chauhan, Anuj
2015-11-01
About 70% of eyedrops contain benzalkonium chloride (BAK) as a preservative to prevent the growth of microorganisms. While preservatives are mandated to maintain sterility, many patients exhibit irritation and toxicity to such compounds. We propose to mitigate the ocular toxicity in the ocular formulations without compromising sterility by designing a device that can be incorporated into an eyedrops bottle to selectively remove the preservatives during the process of drop instillation. Here, we specifically focus on macroporous poly(2-hydroxyethyl methacrylate) (pHEMA) gel due to its excellent biocompatibility and high partition coefficient for BAK. In addition to specific selectivity for BAK, the device also requires high hydraulic permeability to allow drop dispensing without excessive pressure drop. The pHEMA monolith can remove nearly 100% of contained BAK from a 25 ml, 0.012% BAK solution with negligible uptake of the hydrophilic drugs such as timolol and dorzolamide. The filter, however, had to be pre-equilibrated with hydrophobic drugs to reach a high separation of BAK without reducing the concentration of the active drug. The average hydraulic permeability of the filter was 0.025 Darcy, which is about 5-fold lower than the ideal value. Incorporation of a pHEMA macroporous gel into an eyedrops bottle can virtually eliminate the exposure of the eyes to the preservatives without compromising the sterility. Our novel design can eliminate the preservative induced toxicity from eyedrops thereby impacting hundreds of millions of patients with chronic ophthalmic diseases such as glaucoma and dry eyes. Copyright © 2015 Elsevier B.V. All rights reserved.
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75 FR 9184 - Federal Advisory Committee; Advisory Council on Dependents' Education; Open Meeting
2010-03-01
... 102-3.150, the Department of Defense announces that the Advisory Council on Dependents' Education will... Advisory Council on Dependents' Education about its mission and functions. Written statements may be... Advisory Council on Dependents' Education, Mr. Charles Toth, telephone (703) 588-3105, 4040 North Fairfax...
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77 FR 72365 - National Institute on Drug Abuse; Notice of Meeting
2012-12-05
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of... of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...
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Paradigm Shifts in Ophthalmic Diagnostics.
Sebag, J; Sadun, Alfredo A; Pierce, Eric A
2016-08-01
Future advances in ophthalmology will see a paradigm shift in diagnostics from a focus on dysfunction and disease to better measures of psychophysical function and health. Practical methods to define genotypes will be increasingly important and non-invasive nanotechnologies are needed to detect molecular changes that predate histopathology. This is not a review nor meant to be comprehensive. Specific topics have been selected to illustrate the principles of important paradigm shifts that will influence the future of ophthalmic diagnostics. It is our impression that future evaluation of vision will go beyond visual acuity to assess ocular health in terms of psychophysical function. The definition of disease will incorporate genotype into what has historically been a phenotype-centric discipline. Non-invasive nanotechnologies will enable a paradigm shift from disease detection on a cellular level to a sub-cellular molecular level. Vision can be evaluated beyond visual acuity by measuring contrast sensitivity, color vision, and macular function, as these provide better insights into the impact of aging and disease. Distortions can be quantified and the psychophysical basis of vision can be better evaluated than in the past by designing tests that assess particular macular cell function(s). Advances in our understanding of the genetic basis of eye diseases will enable better characterization of ocular health and disease. Non-invasive nanotechnologies can assess molecular changes in the lens, vitreous, and macula that predate visible pathology. Oxygen metabolism and circulatory physiology are measurable indices of ocular health that can detect variations of physiology and early disease. This overview of paradigm shifts in ophthalmology suggests that the future will see significant improvements in ophthalmic diagnostics. The selected topics illustrate the principles of these paradigm shifts and should serve as a guide to further research and development. Indeed
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2011-08-19
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-074)] NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space... meeting of the NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel...
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Post-marketing surveillance of levofloxacin 0.5% ophthalmic solution for external ocular infections.
Kanda, Yoshiko; Kayama, Tomoko; Okamoto, Shinji; Hashimoto, Masako; Ishida, Chiemi; Yanai, Tomoko; Fukumoto, Mitsuru; Kunihiro, Eiichi
2012-12-01
Levofloxacin 0.5% ophthalmic solution is an antibacterial formulation, which was approved and marketed for the treatment of ocular infections in Japan in 2000. This study was designed to investigate the safety and efficacy of levofloxacin 0.5% ophthalmic solution in patients who received treatment for external ocular bacterial infections in regular clinical practice. Patients were recruited from more than 800 medical facilities in Japan, in accordance with Japanese Ministry of Health, Labour and Welfare ordinance guidelines. They were followed during three distinct time periods: April 2000 to December 2001, January 2002 to June 2003, and July 2003 to December 2004. Information from 6760 patients receiving levofloxacin for the treatment of a variety of ocular infections was collected. Levofloxacin was well tolerated: adverse drug reactions (ADRs) were reported in 42 of 6686 patients (0.63%), with no serious ADRs reported. The most commonly reported ADRs were ocular disorders such as blepharitis, eye irritation, and punctate keratitis. The incidence of ADRs did not differ significantly with age, but it was significantly higher in females (0.82%) than in males (0.36%; p = 0.028). A clinical response was observed in 95.5% of patients receiving levofloxacin, with no difference in response between the three time periods. The rate of response to levofloxacin by bacterial disease ranged from 97.4% in keratitis to 88.3% in dacryocystitis. The rate was lower in patients with dacryocystitis, elderly patients, patients with a long duration of illness, and relapsing cases (all p marketing surveillance of levofloxacin, conducted over 4 years, confirms the safety and efficacy of levofloxacin in regular clinical use and highlights that levofloxacin is a promising treatment for a variety of external ocular bacterial infections.
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76 FR 51381 - National Institute on Drug Abuse; Notice of Meeting
2011-08-18
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of.... (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...
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76 FR 81952 - National Institute on Drug Abuse; Notice of Meeting
2011-12-29
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health...: Teresa Levitin, Ph.D., Director, Office of Extramural Affairs, National Institute on Drug Abuse, NIH...
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75 FR 14176 - National Institute on Drug Abuse; Notice of Meeting
2010-03-24
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... announcements and reports of administrative, legislative and program developments in the drug abuse field. Place... Person: Teresa Levitin, PhD, Director, Office of Extramural Affairs, National Institute on Drug Abuse...
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77 FR 52752 - National Institute on Drug Abuse; Notice of Meeting
2012-08-30
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health... Drug Abuse, NIH, DHHS, Room 4243, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892-89550, (301...
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75 FR 42100 - National Institute on Drug Abuse; Notice of Meeting
2010-07-20
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health...: Teresa Levitin, PhD, Director, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS...
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Optimization and evaluation of thermoresponsive diclofenac sodium ophthalmic in situ gels.
Asasutjarit, Rathapon; Thanasanchokpibull, Suthira; Fuongfuchat, Asira; Veeranondha, Sukitaya
2011-06-15
This work was conducted to optimize and evaluate Pluronic F127-based thermoresponsive diclofenac sodium ophthalmic in situ gels (DS in situ gel). They were prepared by cold method and investigated their physicochemical properties i.e., pH, flow ability, sol-gel transition temperature, gelling capacity and rheological properties. An optimized formulation was selected and investigated its physicochemical properties before and after autoclaving, eye irritation potency in SIRC cells and rabbits. In vivo ophthalmic absorption was performed in rabbits. It was found that physicochemical properties of DS in situ gels were affected by formulation compositions. Increment of Pluronic F127 content decreased sol-gel transition temperature of the products while increase in Pluronic F68 concentration tended to increase sol-gel transition temperature. In this study, Carbopol 940 did not affect sol-gel transition temperature but it affected transparency, pH, and gelling capacity of the products. The optimized formulation exhibited sol-gel transition at 32.6 ± 1.1 °C with pseudoplastic flow behavior. It was lost diclofenac sodium content during autoclaving. However, it was accepted as safe for ophthalmic use and could increase diclofenac sodium bioavailability in aqueous humor significantly. In conclusion, the optimized DS in situ gel had potential for using as an alternative to the conventional diclofenac sodium eye drop. However, autoclaving was not a suitable sterilization method for this product. Copyright © 2011 Elsevier B.V. All rights reserved.
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Local toxicity of benzalkonium chloride in ophthalmic solutions following repeated applications.
Okahara, Akihiko; Kawazu, Kouichi
2013-01-01
We performed repeated toxicity studies of benzalkonium chloride (BAK)-containing vehicles of ophthalmic solutions in monkeys and rabbits to assess the local toxicity of BAK after repeated applications on the ocular surface. Local toxicity of BAK was evaluated by toxicity studies in which a 0.01% BAK-containing vehicle was applied twice/day for 52 weeks, 4 times/day for 39 weeks, or 6 times/day for 13 weeks, or in which a 0.005% BAK-containing vehicle was applied 6 times/day for 52 weeks or twice/day for 4 weeks in monkeys. Local toxicity of BAK was also evaluated where a 0.01% BAK-containing vehicle was applied 6 times/day for 6 weeks, or a 0.005% BAK-containing vehicle was applied twice/day for 39 weeks or 8 times/day for 4 weeks in rabbits. These doses were chosen because BAK is generally used at concentrations up to 0.01% in ophthalmic solutions. The BAK-containing vehicle did not cause ophthalmological changes suggestive of irritation, allergy, or corneal damage. We also did not observe any histopathological changes in the eyeball, eyelid, lacrimal gland, and nasal cavity, with repeated applications of BAK for up to 52 weeks, up to 8 times/day, or at concentrations up to 0.01%, in monkeys and rabbits. Our results suggest that BAK in concentrations up to 0.01% in ophthalmic solution is non-toxic to the eyeball, its accessory organs, and the nasal cavity after long repeated applications.
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2011-08-23
... DEPARTMENT OF DEFENSE Notice of Advisory Committee Closed Meeting; U.S. Strategic Command Strategic Advisory Group AGENCY: Department of Defense. ACTION: Notice of Advisory Committee closed meeting.... Strategic Command Strategic Advisory Group. DATES: November 1, 2011, from 8 a.m. to 5 p.m. and November 2...
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Murias, E; Villota, E; Saiz, A; Gil, A; Calleja, S
2009-01-01
Sinus pericranii is an abnormal venous communication between the intracranial dural sinuses and epicranial venous dilatations. The periorbital location is uncommon; spontaneous partial thromboses of the subcutaneous varices have been reported in association with local signs and symptoms; however, to our knowledge there are no reports of sinus pericranii associated to thrombosis in the ophthalmic vein. Sinus pericranii is related to arteriovenous and lymphatic-venous malformations. We present the case of a patient with a generalized and diffuse disorder of venous drainage that affected the right cerebral hemisphere who presented at the emergency department with ophthalmologic signs and symptoms after thrombosis of the superior ophthalmic vein and who had three sinus pericranii located in the frontal, parietal, and occipital areas.
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77 FR 22581 - National Institute on Drug Abuse; Notice of Meeting
2012-04-16
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... developments in the drug abuse field. Place: National Institutes of Health, Neuroscience Center, 6001 Executive..., Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4243, MSC 9550, 6001...
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Antimicrobial activity of a new preservative for multiuse ophthalmic solutions.
Ghelardi, Emilia; Celandroni, Francesco; Gueye, Sokhna A; Salvetti, Sara; Campa, Mario; Senesi, Sonia
2013-01-01
The aim of this study was to examine the antimicrobial activity and the preservative efficacy of a novel preservative solution containing sodium hydroxymethyl glycinate (SHMG) and edetate disodium (EDTA), which is used for preservation of some commercial ophthalmic formulations. In vitro susceptibility assays were performed against several gram-positive (Staphylococcus aureus, Staphylococcus epidermidis, and Bacillus cereus) and gram-negative (Escherichia coli and Pseudomonas aeruginosa) bacteria representative of the microbial flora of epithelial surfaces or colonizing the conjunctiva, as well as against Candida albicans and Aspergillus niger. Using different concentrations of SHMG alone or in combination with EDTA, the minimal inhibitory and microbicidal concentrations against these organisms were assessed. In addition, 8 brands of multidose eye drops containing 0.002% SHMG and 0.1% EDTA as preservative were tested for antimicrobial activity using the antimicrobial effectiveness test recommended by the international pharmacopoeias. The minimal inhibitory and bactericidal/fungicidal concentration values of SHMG ranged from 0.0025% to 0.0125% for bacteria and from 0.125% to 0.50% for mold and yeast. Susceptibility testing demonstrated that the addition of EDTA substantially increased the SHMG activity against all bacterial and fungal strains. The preservative effectiveness test was applied to commercial eye drops. All the drop solutions met the criteria reported by the U.S. Pharmacopeia for parenteral and ophthalmic preparations. All products also satisfied the major acceptance criteria of the European Pharmacopeia with respect to the antifungal activity. With regard to the antibacterial activity, the less-stringent criteria of the European Pharmacopeia were fulfilled. The present study demonstrates the efficacy of a novel preservative for ophthalmic solutions (SHMG/EDTA) and its activity in protecting selected commercial artificial tears against microbial
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Ophthalmic manifestations of methylmalonic aciduria accompanied with homocystinuria
Directory of Open Access Journals (Sweden)
Qiu-Jing Huang
2015-12-01
Full Text Available Methylmalonicaciduia(MMAaccompanied with homocystinuria is a rare autosomal-recessive with congenital metabolic disorder of Vitamin B12. There are three subtypes, cblC, cblD, cblF, in which cblC is the most common one. The diagnostic tests are tandem mass spectrometry and gas chromatography-mass spectrometry. Tests for activity of enzyme in fibroblasts from skin, complementary assay and genetic analysis can be used to make the subtype clear. Early-onset patients, defined by onset of symptoms before the age of 1 year, may have severe ocular involvement, including visual loss, nystagmus, strabismus, retinopathy, maculopathy, optic atrophy, abnormal electroretinography. Late-onset patients, defined by onset of symptoms after the age of 4 year, rarely have ocular manifestations. The pathogenesis of the ophthalmic symptoms may be related to the high level of homocystine, oxidative stress and the abnormal development of nervous systems. The treatment for MMA accompanied with homocystinuria is mostly symptomatic based. Ophthalmic treatment is limited. Early supplement of methionine,GSH or other antioxidants may be helpful for retinopathy. There is no standard ophthalmological examination for those patients in China. It is critical to set up inter-departmental cooperation and early stage examination for the treatments and outcomes of the patients.
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Directory of Open Access Journals (Sweden)
Sofia Ahmed
2017-01-01
Full Text Available Introduction: Sulfacetamide sodium is a widely used sulfonamide for ophthalmic infections. Objective: A number of analytical methods have been reported for the analysis of sulfacetamide but they lack the ability to determine both the active drug and its major degradation product, sulfanilamide, simultaneously in a sample. Materials and Methods: In the present study a simple, rapid and economical stability-indicating UV spectrometric method has been validated for the simultaneous assay of sulfacetamide sodium and sulfanilamide in pure form and in ophthalmic preparations. Results: The method has been found to be accurate (recovery 100.03 ±0.589% and precise (RSD 0.587% with detectable and quantifiable limits of 1.67×10–6 M (0.04 mg% and 5.07×10–6 M (0.13 mg%, respectively for the assay of pure sulfacetamide sodium. The method is also found to be accurate and precise to small changes in wavelength, pH and buffer concentration as well as to forced degradation. The study further includes the validation of the method for the assay of pure sulfanilamide in solution, which has been found to be accurate, precise and robust. Conclusion: The results indicate that the proposed two-component spectrometric method is stability-indicating and can be used for the simultaneous assay of both sulfacetamide sodium and sulfanilamide in synthetic mixtures and degraded solutions.
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Ophthalmic Skills Assessment of Primary Health Care Workers at ...
African Journals Online (AJOL)
Proficiency in the basic ophthalmic skills is a cri cal factor in the effec ve delivery of eye care services at the primary level of care. The aim of the study was to assess the ability of ... out visual acuity test and correctly iden fy cataract and conjunc vi s using pictures of eye condi ons and ..... Medical Laboratory Technician.
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78 FR 45252 - National Institute on Drug Abuse; Notice of Meeting
2013-07-26
... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... on Drug Abuse. Date: September 4, 2013. Closed: 8:30 AM to 10:30 AM. Agenda: To review and evaluate... program developments in the drug abuse field. Place: National Institutes of Health, Neuroscience Center...
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2017-01-03
following ocular surgery.1 They are available in different forms including emulsions , ointments, solutions, gels, and suspensions. The choice of...study done by Stringer and Bryant compared dose uniformity of difluprednate ophthalmic emulsion (Durezol®) with prednisolone acetate (brand name...topical ophthalmic corticosteroid suspensions. Am J Ophthalmol. 1979;87(2): 210- 214. 5 Flarex® [ package insert]. Fort Worth, TX: Alcon Laboratories Inc
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2012-05-01
... DEPARTMENT OF DEFENSE Notice of Advisory Committee Closed Meeting; U.S. Strategic Command Strategic Advisory Group AGENCY: Department of Defense. ACTION: Notice of Advisory Committee closed meeting.... [[Page 25707
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A drug's life: the pathway to drug approval.
Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A
2013-10-01
In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.
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Common causes of red eye presenting at an ophthalmic clinic ...
African Journals Online (AJOL)
Background: Redness of the eye is a common ophthalmic symptom. The problem causing redness could arise from within or outside the globe. These range from cases of simple inflammation following itching and minor trauma for example, to severe cases like orbital cellulitis and tumours. Patients may not even be aware of ...
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Efficacy of detergent and water versus bleach for disinfection of direct contact ophthalmic lenses.
Abbey, Ashkan M; Gregori, Ninel Z; Surapaneni, Krishna; Miller, Darlene
2014-06-01
Although manufacturers recommend cleaning ophthalmic lenses with detergent and water and then with a specific disinfectant, disinfectants are rarely used in ophthalmic practices. The aim of this pilot study was to evaluate the efficacy of detergent and water versus that of bleach, a recommended disinfectant, to eliminate common ocular bacteria and viruses from ophthalmic lenses. Three bacterial strains (Staphylococcus epidermidis, Corynebacterium straitum, and methicillin-resistant Staphylococcus aureus and 2 viral strains (adenovirus and herpes simplex virus [HSV] type-1) were individually inoculated onto 20 gonioscopy and laser lenses. The lenses were washed with detergent and water and then disinfected with 10% bleach. All the lenses were cultured after inoculation, after washing with detergent and water, and after disinfecting with the bleach. Bacterial cultures in thioglycollate broth were observed for 3 weeks, and viral cultures were observed for 2 weeks. The presence of viruses was also detected by multiplex polymerase chain reaction (PCR). All 20 lenses inoculated with S. epidermidis, C. straitum, adenovirus, and HSV-1 showed growth after inoculation but no growth after washing with detergent/water and after disinfecting with the bleach. All lenses showed positive HSV and adenovirus PCR results after inoculation and negative PCR results after washing with detergent/water and after disinfecting with bleach. All methicillin-resistant S. aureus-contaminated lenses showed growth after inoculation and no growth after washing with detergent and water. However, 1 lens showed positive growth after disinfecting with bleach. Cleaning with detergent and water seemed to effectively eliminate bacteria and viruses from the surface of contaminated ophthalmic lenses. Further studies are warranted to design practical disinfection protocols that minimize lens damage.
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Facilitation of tear fluid secretion by 3% diquafosol ophthalmic solution in normal human eyes.
Yokoi, Norihiko; Kato, Hiroaki; Kinoshita, Shigeru
2014-01-01
To evaluate the increase in tear fluid volume induced by 3% diquafosol ophthalmic solution in normal human eyes. Prospective, randomized, double-masked, comparative study. Twenty healthy adults (17 males and 3 females; mean age, 38.8 years) underwent topical instillation of 2 ophthalmic solutions, artificial tears in 1 eye and 3% diquafosol ophthalmic solution in the fellow eye, in a masked manner. The radius of curvature of the central lower tear meniscus was measured at 5, 10, 15, 30, and 60 minutes after instillation by use of reflective meniscometry, and subjects' self-evaluated symptoms of wetness and stinging using a visual analog scale. Changes after instillation in the radius of curvature from baseline (artificial tear group vs diquafosol group; mean ± standard error of the mean) were as follows: at 5 minutes, -0.008 ± 0.012 vs 0.045 ± 0.013; at 10 minutes, 0.001 ± 0.014 vs 0.057 ± 0.016; at 15 minutes, -0.012 ± 0.014 vs 0.037 ± 0.019; at 30 minutes, -0.010 ± 0.016 vs 0.030 ± 0.025; and at 60 minutes, -0.029 ± 0.012 vs -0.020 ± 0.012. The diquafosol group showed significantly greater values from 5 to 30 minutes after instillation. Of the 40 eyes, 13 showed abnormal tear film breakup time (≤5 seconds). The diquafosol group had significantly more wetness at 15 minutes after instillation than did the artificial tear group. Topical instillation of 3% diquafosol ophthalmic solution increases tear fluid on the ocular surface for up to 30 minutes in normal human eyes. Copyright © 2014 Elsevier Inc. All rights reserved.
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Ishii, Masashi; Hayashi, Morito; Yagi, Fumihiko; Sato, Kenichiro; Tomita, Goji; Iwabuchi, Satoshi
2016-01-01
When internal carotid artery stenosis is accompanied by ocular ischemic syndrome, intervention is recommended to prevent irreversible visual loss. In this study, we used laser speckle flowgraphy to measure the ocular microcirculation in the optic nerve head before and after carotid artery stenting (CAS) of 40 advanced internal carotid stenosis lesions from 37 patients. The aim was to investigate the relationship between ocular microcirculation and the direction of ophthalmic artery blood flow obtained by angiography. We found that there was a significant increase in blood flow after CAS ( P = 0.003). Peak systolic velocity as an indicator of the rate of stenosis was also significantly higher in the group with retrograde/undetected flow of the ophthalmic artery than in the group with antegrade flow ( P = 0.002). In all cases where retrograde flow of the ophthalmic artery was observed before stenting, the flow changed to antegrade after stenting. Through the use of laser speckle flowgraphy, this study found that CAS can improve ocular microcirculation. Furthermore, while patients displaying retrograde flow of the ophthalmic artery before stenting have a poor prognosis, CAS corrected the flow to antegrade, suggesting that visual loss can be prevented by improving the ocular microcirculation.
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O'Gallagher, M K; Lewis, G; Mercieca, K; Moutray, T
2013-01-01
To assess ophthalmic trainees' perspective of the impact of the European Working Time Regulations (EWTR) on their training. All trainees in ophthalmology in the UK were emailed a link to an electronic survey asking about their experiences of the EWTR. 324 trainees (46% of those invited) responded to the survey. 44.4% of trainees reported that their posts were compliant with the EWTR. 40.7% felt that training had been adversely affected. 49.1% thought that ophthalmic trainees should opt out of the EWTR to work more than 48 h per week, with 57 the mean number of hours suggested appropriate. Many ophthalmic trainees in the United Kingdom are working in rotas which are not compliant with the European Working Time Directive. Many trainees feel that implementation of the EWTD has had a negative effect on training and feel it would be acceptable to work a higher number of hours per week. Copyright © 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
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OPHTHALMIC FINDINGS IN LATE STAGE SJOGREN-LARSSON SYNDROME.
Nanda, Tavish; Kovach, Jaclyn L
2017-03-15
To report spectral domain optical coherence tomography and fundus autofluorescence documentation of late stage macular findings associated with Sjogren-Larsson Syndrome in three adult siblings. Three adult siblings with Sjogren-Larsson Syndrome underwent ophthalmic examination and imaging. Crystalline maculopathy and subretinal deposits, presumably lipofuscin accumulation, with macular atrophy were present in varying degrees in all three adult siblings. In adults with Sjogren-Larsson Syndrome, crystalline retinopathy can progress to macular atrophy and the appearance of lipofuscin accumulation.
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Abbey, Ashkan M.; Gregori, Ninel Z.; Surapaneni, Krishna; Miller, Darlene
2014-01-01
Purpose While manufacturers recommend cleaning ophthalmic lenses with detergent and water and then a specific disinfectant, disinfectants are rarely used in ophthalmic practices. The aim of this pilot study was to evaluate the efficacy of detergent and water versus bleach, a recommended disinfectant, to eliminate common ocular bacteria and viruses from ophthalmic lenses. Methods Three bacterial strains (Staphylococcus epidermidis, Corynebacterium straitum, and methicillin-resistant Staphylococcus aureus (MRSA) and two viral strains (adenovirus and herpes simplex virus (HSV) type-1) were individually inoculated to 20 gonioscopy and laser lenses. Lenses were washed with detergent and water and then disinfected with 10% bleach. All lenses were cultured after inoculation, after detergent and water, and after the bleach. Bacterial cultures in thioglycollate broth were observed for 3 weeks and viral cultures for 2 weeks. The presence of viruses was also detected by multiplex polymerase chain reaction (PCR). Results All 20 lenses inoculated with Staphylococcus epidermidis, Corynebacterium straitum, adenovirus, and HSV-1 showed growth after inoculation, but no growth after detergent/water and after the bleach. All lenses showed positive HSV and adenovirus PCR after inoculation and negative PCR after detergent/water and after bleach. All MRSA contaminated lenses showed growth after inoculation and no growth after detergent and water. However, one lens showed positive growth after bleach. Conclusions Cleaning with detergent and water appeared to effectively eliminate bacteria and viruses from the surface of contaminated ophthalmic lenses. Further studies are warranted to design practical disinfection protocols that minimize lens damage. PMID:24747806
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Ion-Responsive Drug Delivery Systems.
Yoshida, Takayuki; Shakushiro, Kohsuke; Sako, Kazuhiro
2018-02-08
Some kinds of cations and anions are contained in body fluids such as blood, interstitial fluid, gastrointestinal juice, and tears at relatively high concentration. Ionresponsive drug delivery is available to design the unique dosage formulations which provide optimized drug therapy with effective, safe and convenient dosing of drugs. The objective of the present review was to collect, summarize, and categorize recent research findings on ion-responsive drug delivery systems. Ions in body fluid/formulations caused structural changes of polymers/molecules contained in the formulations, allow formulations exhibit functions. The polymers/molecules responding to ions were ion-exchange resins/fibers, anionic or cationic polymers, polymers exhibiting transition at lower critical solution temperature, self-assemble supramolecular systems, peptides, and metalorganic frameworks. The functions of ion-responsive drug delivery systems were categorized to controlled drug release, site-specific drug release, in situ gelation, prolonged retention at the target sites, and enhancement of drug permeation. Administration of the formulations via oral, ophthalmic, transdermal, and nasal routes has showed significant advantages in the recent literatures. Many kinds of drug delivery systems responding to ions have been reported recently for several administration routes. Improvement and advancement of these systems can maximize drugs potential and contribute to patients in the world. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.
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2012-10-19
... ENVIRONMENTAL PROTECTION AGENCY [FRL--9743-2] Notification of a Public Teleconference of the Science Advisory Board; Perchlorate Advisory Panel AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office...
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Ellis, Michael P; Broxterman, Emily C; Hromas, Alan R; Whittaker, Thomas J; Sokol, Jason A
2018-01-10
Surgical management of ophthalmic Graves' disease traditionally involves, in order, orbital decompression, followed by strabismus surgery and eyelid surgery. Nunery et al. previously described two distinct sub-types of patients with ophthalmic Graves' disease; Type I patients exhibit no restrictive myopathy (no diplopia) as opposed to Type II patients who do exhibit restrictive myopathy (diplopia) and are far more likely to develop new-onset worsening diplopia following medial wall and floor decompression. Strabismus surgery involving extra-ocular muscle recession has, in turn, been shown to potentially worsen proptosis. Our experience with Type II patients who have already undergone medial wall and floor decompression and strabismus surgery found, when additional decompression is necessary, deep lateral wall decompression (DLWD) appears to have a low rate of post-operative primary-gaze diplopia. A case series of four Type II ophthalmic Graves' disease patients, all of whom had already undergone decompression and strabismus surgery, and went on to develop worsening proptosis or optic nerve compression necessitating further decompression thereafter. In all cases, patients were treated with DLWD. Institutional Review Board approval was granted by the University of Kansas. None of the four patients treated with this approach developed recurrent primary-gaze diplopia or required strabismus surgery following DLWD. While we still prefer to perform medial wall and floor decompression as the initial treatment for ophthalmic Graves' disease, for proptosis following consecutive strabismus surgery, DLWD appears to be effective with a low rate of recurrent primary-gaze diplopia.
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Heslop, Emma; Csimma, Cristina; Straub, Volker; McCall, John; Nagaraju, Kanneboyina; Wagner, Kathryn R; Caizergues, Didier; Korinthenberg, Rudolf; Flanigan, Kevin M; Kaufmann, Petra; McNeil, Elizabeth; Mendell, Jerry; Hesterlee, Sharon; Wells, Dominic J; Bushby, Kate
2015-04-23
Despite multiple publications on potential therapies for neuromuscular diseases (NMD) in cell and animal models only a handful reach clinical trials. The ability to prioritise drug development according to objective criteria is particularly critical in rare diseases with large unmet needs and a limited numbers of patients who can be enrolled into clinical trials. TREAT-NMD Advisory Committee for Therapeutics (TACT) was established to provide independent and objective guidance on the preclinical and development pathway of potential therapies (whether novel or repurposed) for NMD.We present our experience in the establishment and operation of the TACT. TACT provides a unique resource of recognized experts from multiple disciplines. The goal of each TACT review is to help the sponsor to position the candidate compound along a realistic and well-informed plan to clinical trials, and eventual registration. The reviews and subsequent recommendations are focused on generating meaningful and rigorous data that can enable clear go/no-go decisions and facilitate longer term funding or partnering opportunities. The review process thereby acts to comment on viability, de-risking the process of proceeding on a development programme.To date TACT has held 10 review meeting and reviewed 29 program applications in several rare neuromuscular diseases: Of the 29 programs reviewed, 19 were from industry and 10 were from academia; 15 were for novel compounds and 14 were for repurposed drugs; 16 were small molecules and 13 were biologics; 14 were preclinical stage applications and 15 were clinical stage applications. 3 had received Orphan drug designation from European Medicines Agency and 3 from Food and Drug Administration. A number of recurrent themes emerged over the course of the reviews and we found that applicants frequently require advice and education on issues concerned with preclinical standard operating procedures, interactions with regulatory agencies, formulation
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Digital video recording and archiving in ophthalmic surgery
Directory of Open Access Journals (Sweden)
Raju Biju
2006-01-01
Full Text Available Currently most ophthalmic operating rooms are equipped with an analog video recording system [analog Charge Couple Device camera for video grabbing and a Video Cassette Recorder for recording]. We discuss the various advantages of a digital video capture device, its archiving capabilities and our experience during the transition from analog to digital video recording and archiving. The basic terminology and concepts related to analog and digital video, along with the choice of hardware, software and formats for archiving are discussed.
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Black Hawk Coll., Moline, IL.
An advisory committee is generally comprised of persons outside the education profession who have specialized knowledge in a given area. The committee advises, makes recommendations, and gives service to the college and its students, instructors, and administrators. At Black Hawk College, there are four types of advisory committees: community,…
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10 CFR 35.491 - Training for ophthalmic use of strontium-90.
2010-01-01
... the requirements in paragraph (b) of this section and has achieved a level of competency sufficient to... require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who— (a) Is an...; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology...
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Influence of Ophthalmic Solutions on Tear Components.
Shigeyasu, Chika; Yamada, Masakazu; Akune, Yoko
2016-11-01
Tear fluids are a mixture of secretions derived from lacrimal glands, accessory lacrimal glands, conjunctiva, and meibomian glands. Compositional changes to tears occur in the normal state and during ocular surface disease, such as dry eye conditions. We have investigated compositional changes to tears after topical application of ophthalmic solutions, with regard to tear-specific proteins (secretory immunoglobulin A, lactoferrin, lipocalin-1, and lysozyme) and ocular surface mucin in normal and dry eye conditions using high-performance liquid chromatography. After application of saline solution (0.9% sodium chloride) in normal subjects, transient but significant decreases in all tear components were observed. The recovery of protein concentrations took up to 30 minutes and lasted longer when the saline solution was applied more frequently. When applying ophthalmic solutions, a balance between washout and dilutional effects should be considered in addition to the therapeutic effect. Investigation of the effect of diquafosol solution (3%) in normal subjects revealed a significant increase in sialic acid concentration, a marker of ocular mucin, at 5 minutes after application, whereas a significant decrease was observed with saline. This result indicates the accelerated secretion of mucin from ocular tissues induced by diquafosol. A clinical study to determine the efficacy of diquafosol in patients with dry eye revealed improvements in tear breakup time, keratoconjunctival staining scores, and Schirmer test score, accompanied by an increase in sialic acid concentration in tears. Investigating normal and dry eye conditions through tear analysis may clarify the pathophysiology of dry eye conditions and support the efficacy of treatments.
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International Nuclear Information System (INIS)
Matsuo, Toshihiko; Ohara, Nobuya; Namba, Yuzaburo; Koshima, Isao; Ida, Kentaro; Kanazawa, Susumu
2009-01-01
The aim of this study is to describe the effect of transarterial embolization from the ophthalmic artery as a pretreatment for orbital exenteration. A 75-year-old Chinese man with a 7-year history of gradual increase of the left eye swelling showed a massive conjunctival tumor growing outwardly from the interpalpebral fissure and had no light perception in the left eye. Magnetic resonance imaging showed orbital invasion of the tumor around the left eyeglobe. The initial surgery for the planned orbital exenteration was discontinued after skin incision around the orbital margin due to massive hemorrhage. The patient underwent transarterial embolization with gelatin sponge (Spongel) of the feeding arteries from the left ophthalmic artery and, the next day, had orbital exenteration with well-controllable bleeding and reconstruction with free vascularized anterolateral thigh cutaneous flap transfer. Pathologically, well-differentiated squamous cell carcinoma proliferated in exophytic, papillary, and nested fashions, arising from the bulbar conjunctiva. Tumor cells were also found in the conjunctival stroma around the vessels. The sclera at the equator had a perforated site with tumor cell invasion, but no intraocular invasion was found. Hematoxylin-positive gelatin sponges were found inside the orbital vessels and large choroidal vessels. In conclusion, transarterial embolization of feeding arteries arising from the ophthalmic artery is a useful pretreatment to control bleeding at orbital exenteration for malignancy.
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Flow analysis of the ophthalmic artery
Energy Technology Data Exchange (ETDEWEB)
Harada, Kuniaki; Hashimoto, Masato; Bandoh, Michio; Odawara, Yoshihiro; Kamagata, Masaki; Shirase, Ryuji [Sapporo Medical Univ. (Japan). Hospital
2003-02-01
The purpose of this study was to analyze the hemodynamics of ophthalmic artery flow using phase contrast MR angiography (PC-MRA). A total of 14 eyes from 10 normal volunteers and a patient with normal tension glaucoma (NTG) were analyzed. The optimal conditions were time repetition (TR)/echo time (TE)/flip angle (FA)/nex=40 ms/minimum/90 deg/2, field of view (FOV)=6 cm, matrix size=256 x 256. The resistive index (RI) and pulsatillity index (PI) values were significantly raised in the patient with NTG when compared to the control group. We therefore believe that PC-MRA may be a useful clinical tool for the assessment of the mechanism of NTG. (author)
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Safety comparison of additives in antiglaucoma prostaglandin (PG analog ophthalmic formulations
Directory of Open Access Journals (Sweden)
Fukuda M
2013-03-01
Full Text Available Masamichi Fukuda, Shinsuke Shibata, Naoko Shibata, Kenta Hagihara, Hiromoto Yaguchi, Hiromi Osada, Nobuo Takahashi, Eri Kubo, Hiroshi SasakiDepartment of Ophthalmology, Kanazawa Medical University, Uchinada, JapanPurpose: To investigate the safety of five types of antiglaucoma prostaglandin analog ophthalmic formulations, and to clarify their differences in accordance with contained additives (preservatives and surface-active agents.Methods: The following five types of ophthalmic solutions and three types of additives were investigated: latanoprost (Xalatan®; latanoprost, tafluprost (Tapros®; tafluprost, bimatoprost (Lumigan®; bimatoprost, travoprost (Travatan®; travoprost, travoprost (Travatan Z®; travoprost-Z, benzalkonium chloride (BAK, polyoxyethylene hardening castor oil 40 (HCO-40, and polysorbate 80 (P-80. These experimental solutions were exposed to the cultured cells of a rabbit-derived corneal cell line for a certain time, and the exposure time causing 50% cell damage (CD50, indicated by the ratio of viable cells to total cells was calculated (in vitro. In addition, corneal resistance (CR was measured and CR ratio (post-treatment CR/pretreatment CR × 100 was calculated (in vivo.Results: CD50 of each ophthalmic solution was the longest with tafluprost, followed by travoprost-Z, bimatoprost, travoprost, and latanoprost. CD50 of 0.005%, 0.01%, and 0.02% BAK was 14.5 minutes, 8.1 minutes, and 4.0 minutes, respectively. The number of viable cells decreased to 60%, 8 minutes after exposure with HCO-40, and 30 minutes after being exposed to P-80. The CR ratio was 81.0% with travoprost and 82.0% with latanoprost, indicating a significant posttreatment reduction of CR (P < 0.05. The CR ratio did not decrease after treatment with tafluprost, travoprost-Z, or bimatoprost. The CR ratio of 0.005%, 0.01%, and 0.02% BAK was 105.0%, 90.5%, and 68.7%, respectively, and that of HCO-40 and P-80 was 108.7% and 114.2%, respectively.Conclusion: BAK
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2010-06-14
... Closed Meetings of the Science Advisory Board's Scientific and Technological Achievement Awards Committee... Agency's (EPA), Science Advisory Board (SAB) Staff Office announces a meeting and teleconference of the....gov . The SAB Mailing address is: U.S. EPA Science Advisory Board (1400F), U.S. Environmental...
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Directory of Open Access Journals (Sweden)
Joy Kish
2014-10-01
Full Text Available The purpose of this study was to determine the characteristics and motivational factors of effective Extension advisory leaders. This Delphi study was conducted with a selected group of County Extension Directors and a group of Extension State Advisory Leaders. The study identified 10 characteristics that distinguish an effective Extension advisory leader. Some of these characteristics are explicit and easy to observe, while others are implicit and difficult to directly observe. Therefore, it is practical to use directly observable characteristics of effective advisory leaders when selecting volunteers. Once potential volunteers are spotted in the community, implicit characteristics of effective advisory leaders should be used to further screen them before they are selected. The study also identified the eight most important factors motivating individuals to volunteer as effective advisory leaders. Understanding these motivational factors is helpful for creating an environment for attracting and retaining effective volunteers. Understanding their motivation for volunteer work and creating an environment for them to meet the motivating factors for volunteering will lead to volunteer satisfaction and retention. The findings of this study can be used to build strong Extension advisory councils.
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Nonomura, Sakiko; Oshitari, Toshiyuki; Miura, Gen; Chiba, Akihiro; Yamamoto, Shuichi
2014-09-01
We report a case of unilateral blindness due to ophthalmic artery occlusion following injection of hyaluronic acid into the glabellar area for facial soft-tissue augmentation. A 20-year old woman underwent injection of hyaluronic acid into the glabellar area at an aesthetic plastic clinic. Immediately after injection, she suffered nausea, pain, paralysis of limbs and visual loss in her right eye. Hyaluronidase was instanly injected into the same place, but these symptoms did not improve. She was transferred to our hospital's emergency department. At the first examination, she had no light perception in the right eye and her right pupil was dilated. The fundus examination revealed right central artery occlusion. No significant findings were detected in her head. Eye ball massage, hyperbaric oxygen therapy, and drip infusion of urokinase were conducted, but no improvement resulted. Fluorescein and indocyanine green angiography showed no filling of the right retinal and choroidal arteries. Electroretinogram was completely disappeared. Magnetic resonance angiography could not reveal the obstruction point of the ophthalmic artery. Ophthalmic artery occlusion was believed to have occured after injection of hyaluronic acid into the glabellar area.
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2011-07-27
... Closed Meetings of the Science Advisory Board's Scientific and Technological Achievement Awards Committee... Agency's (EPA), Science Advisory Board (SAB) Staff Office announces a meeting and teleconference of the[email protected] . The SAB Mailing address is: U.S. EPA Science Advisory Board (1400R), U.S. Environmental...
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Ge, Jian; Li, Xiaoxin; Sun, Xinghuai; He, Xiangge; Zhang, Hong
2015-02-01
To confirm the non-inferiority of the IOP-lowering effect of the 0.0015% Tafluprost ophthalmic solution to the 0.005% Latanoprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.Safety was also compared between two groups. This study was conducted from August 2008 to December 2009, at five clinical trial sites in China. Patients of this study population was diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes.Subjects were randomized into 0.0015% Tafluprost group or 0.005% Latanoprost group.Intraocular pressure (IOP) measurement by Goldmann applanation tonometer, slit-lamp microscopy, Gonioscopy, Fundascopy, Visual acuity test, Perimetry, Blood pressure and pulse rate, Subjective symptoms were compered between two groups at Week 0, Week 2 and Week 4.For main effectiveness evaluation index adopt the bad effect evaluation, safety evaluation index by Fisher's exact test probability method. The 246 subjects/246 eyes were randomized (Tafluprost group:122 subjects/122 eyes, Latanoprost group:124 subjects/ 124 eyes). Change in the IOP at 17:00 of Week 2 is (8.8 ± 3.8) mmHg and (8.9 ± 4.4) mmHg (1 mmHg = 0.133 kPa) in Tafluprost group and Latanoprost group. Percent change in the IOP at 17:00 of Week 2 is (33.2 ± 12.8)% and (34.4 ± 14.1)% in Tafluprost group and Latanoprost group. Change in the IOP at 17:00 at the end of treatment is (9.8 ± 4.0) mmHg and (9.2 ± 4.1) mmHg in Tafluprost group and Latanoprost group. Percent change in the IOP at 17:00 at the end of treatment is 37.2% ± 13.4% group and 35.7% ± 13.0% in Tafluprost and Latanoprost group.In addition, distribution of subjects with percentage decrease of IOP > 30% was 72.5% in Tafluprost group higher than 63.8% in Latanoprost group. The major adverse reactions were conjunctival hyperemia, eye irritation, eye pain and foreign body sensation. The incidence of adverse reactions is 31.7% in Tafluprost group and 20.8% in Latanoprost group. The inter
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Progesterone increases resistance of ophthalmic and central retinal arteries in climacteric women.
Souza, M A M De; Souza, B M De; Geber, S
2013-04-01
To evaluate the effect of a synthetic progestin on the vascular resistance of the ophthalmic and central retinal arteries in climacteric women, compared to placebo, using transorbital ultrasound with Doppler velocimetry. We performed a prospective, randomized, double-blinded, placebo-controlled study with 216 climacteric women. Subjects were randomly allocated to one of two groups: either the group receiving placebo (one pill/day for 30 days) (n = 108) or the group receiving progestin (5 mg medroxyprogesterone acetate/day for 30 days) (n = 108). Transorbital Doppler velocimetric ultrasound was performed, before and after treatment; we measured the pulsatility index, resistance index and systole/diastole ratio. The mean ages of the participants in the study group and the control group were 54 ± 6.2 years (range 48-59 years) and 55 ± 6.8 years (range 46-60 years), respectively. When we compared the effect of the progestin on the central retinal artery before and after treatment, we observed a significant increase after the treatment in all Doppler indices. The same was observed when we compared the effect of the progestin on the ophthalmic artery. In the group of women receiving placebo, the Doppler indices were similar before and after treatment. Our results demonstrate the existence of a progestogenic vasoconstrictive effect in the ophthalmic and central retinal arteries. As this study provides new data, the observed effect needs further investigations to better elucidate its extent. Moreover, our findings may be particularly useful to others interested in understanding the vascular dynamics of the cerebral vessels and to researchers running clinical trials related to hormone replacement therapy.
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78 FR 27411 - National Institute on Drug Abuse Notice of Closed Meetings
2013-05-10
... funding cycle. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction... Abuse Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse...
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77 FR 58855 - National Institute on Drug Abuse Notice of Closed Meetings
2012-09-24
....gov . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction... Abuse Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis...
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78 FR 19499 - National Institute on Drug Abuse; Notice of Closed Meeting
2013-04-01
... . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs... Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Profile...
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75 FR 25278 - National Institute on Drug Abuse; Notice of Closed Meeting
2010-05-07
..., MD 21224, (410) 550-1547. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse... Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as... conducted by the National Institute on Drug Abuse, including consideration of personnel qualifications and...
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76 FR 31967 - National Institute On Drug Abuse; Notice of Closed Meetings
2011-06-02
...: National Institute on Drug Abuse Special Emphasis Panel; Predictive Animal Models for Smoking Cessation... Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis...
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2010-03-12
... ENVIRONMENTAL PROTECTION AGENCY [FRL-9126-2] Science Advisory Board Staff Office; Notification of a Public Meeting of the Science Advisory Board (SAB) AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff...
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Association between Ophthalmic Timolol and Hospitalisation for Bradycardia
Directory of Open Access Journals (Sweden)
Nicole L. Pratt
2015-01-01
Full Text Available Introduction. Ophthalmic timolol, a topical nonselective beta-blocker, has the potential to be absorbed systemically which may cause adverse cardiovascular effects. This study was conducted to determine whether initiation of ophthalmic timolol was associated with an increased risk of hospitalisation for bradycardia. Materials and Methods. A self-controlled case-series study was undertaken in patients who were hospitalised for bradycardia and were exposed to timolol. Person-time after timolol initiation was partitioned into risk periods: 1–30 days, 31–180 days, and >180 days. A 30-day risk period prior to initiating timolol was also included. All remaining time was considered unexposed. Results. There were 6,373 patients with at least one hospitalisation for bradycardia during the study period; 267 were exposed to timolol. Risk of bradycardia was significantly increased in the 31–180 days after timolol initiation (incidence rate ratio (IRR = 1.93; 95% confidence interval (CI 1.00–1.87. No increased risk was observed in the first 30 days or beyond 180 days of continuous exposure (IRR = 1.40; 95% CI 0.87–2.26 and IRR = 1.21; 95% CI 0.64–2.31, resp.. Conclusion. Bradycardia is a potential adverse event following timolol initiation. Practitioners should consider patient history before choosing a glaucoma regime and closely monitor patients after treatment initiation with topical nonselective beta-blocker eye drops.
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5 CFR 724.403 - Advisory guidelines.
2010-01-01
... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Advisory guidelines. 724.403 Section 724.403 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...
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Laser tissue welding in ophthalmic surgery.
Rossi, Francesca; Matteini, Paolo; Ratto, Fulvio; Menabuoni, Luca; Lenzetti, Ivo; Pini, Roberto
2008-09-01
Laser welding of ocular tissues is an alternative technique or adjunct to conventional suturing in ophthalmic surgery. It is based on the photothermal interaction of laser light with the main components of the extracellular matrix of connective tissues. The advantages of the welding procedure with respect to standard suturing and stapling are reduced operation times, lesser inflammation, faster healing and increased ability to induce tissue regeneration. The procedure we set up is based on the use of an infrared diode laser in association with the topical application of the chromophore Indocyanine Green. Laser light may be delivered either continuously or in pulses, thus identifying two different techniques that have been applied clinically in various types of transplants of the cornea.
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Ophthalmic compensation of visual ametropia based on a programmable diffractive lens
Millán, Maria S.; Pérez-Cabré, Elisabet; Romero, Lenny A.; Ramírez, Natalia
2013-11-01
Pixelated liquid crystal displays have been widely used as spatial light modulators to implement programmable diffractive optical elements (DOEs), particularly diffractive lenses. Many different applications of such components have been developed in information optics and optical processors that take advantage of their properties of great flexibility, easy and fast refreshment, and multiplexing capability in comparison with equivalent conventional refractive lenses. In this paper, we explore the application of programmable diffractive lenses displayed on the pixelated screen of a liquid crystal on silicon spatial light modulator (LCoS-SLM) to ophthalmic optics. In particular, we consider the use of programmable diffractive lenses for the visual compensation of some refractive errors (myopia, hyperopia). The theoretical principles of compensation are described and sketched using geometrical optics and paraxial ray tracing. A series of experiments with artificial eye in optical bench are conducted to analyze the compensation accuracy in terms of optical power and to compare the results with those obtained by means of conventional ophthalmic lenses. Practical considerations oriented to feasible applications are provided.
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2011-02-09
... ENVIRONMENTAL PROTECTION AGENCY [FRL-9264-5] Science Advisory Board Staff Office; Notification of a Public Meeting of the Science Advisory Board Panel for the Review of EPA's Hydraulic Fracturing...-2098 or via e-mail at [email protected] . General information concerning the EPA Science Advisory...
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Hartman, Rachel R; Kompella, Uday B
Even though the very thought of an injection into the eye may be frightening, an estimated 6 million intravitreal (IVT) injections were made in the USA during 2016. With the introduction of new therapeutic agents, this number is expected to increase. In addition, drug products that are injectable in ocular compartments other than the vitreous humor are expected to enter the back of the eye market in the not so distant future. Besides the IVT route, some of the most actively investigated routes of invasive administration to the eye include periocular, subretinal, and suprachoroidal (SC) routes. While clinical efficacy is the driving force behind new injectable drug product development for the eye, safety is also being improved with time. In the case of IVT injections, the procedural guidelines have evolved over the years to improve patient comfort and reduce injection-related injury and infection. Similar advances are anticipated for other routes of administration of injectable products to the eye. In addition to procedural improvements, the design of needles, particularly those with smaller diameters, length, and controlled bevel angles are expected to improve overall safety and acceptance of injected ophthalmic drug products. A key development in this area is the introduction of microneedles of a length less than a millimeter that can target the SC space. In the future, needles with smaller diameters and lengths, potentially approaching nanodimensions, are expected to revolutionize ophthalmic disease management.
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Energy Technology Data Exchange (ETDEWEB)
Selcuk, Hakan, E-mail: hakanselcuk73@yahoo.com; Soylu, Nur; Albayram, Sait; Selcuk, Dogan; Ozer, Harun; Kocer, Naci; Islak, Civan [Cerrahpasa Medical School, Istanbul University, Department of Radiology, Division of Neuroradiology (Turkey)
2005-04-15
We present the case of a 60-year-old man with persistent epistaxis for 20 days that had started 2 weeks after removal of a nasogastric tube placed for an abdominal operation. There was no pathologic finding at selective facial and internal maxillary artery injections. An injury to the ethmoidal branches of the ophthalmic arteries or other arterial origins of bleeding was suspected. The internal carotid artery angiography revealed a pseudoaneurysm of an anterior ethmoidal branch of the left ophthalmic artery. The pseudoaneurysm was occluded with NBCA-histoacryl (25%) injection.
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International Nuclear Information System (INIS)
Selcuk, Hakan; Soylu, Nur; Albayram, Sait; Selcuk, Dogan; Ozer, Harun; Kocer, Naci; Islak, Civan
2005-01-01
We present the case of a 60-year-old man with persistent epistaxis for 20 days that had started 2 weeks after removal of a nasogastric tube placed for an abdominal operation. There was no pathologic finding at selective facial and internal maxillary artery injections. An injury to the ethmoidal branches of the ophthalmic arteries or other arterial origins of bleeding was suspected. The internal carotid artery angiography revealed a pseudoaneurysm of an anterior ethmoidal branch of the left ophthalmic artery. The pseudoaneurysm was occluded with NBCA-histoacryl (25%) injection
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78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug
2013-11-15
... amendments), as ``preamendments devices.'' FDA classifies these devices after the Agency takes the following.... FDA-2012-N-1238] Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug AGENCY: Food... scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The...
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Matsumoto, Yukihiro; Ohashi, Yuichi; Watanabe, Hitoshi; Tsubota, Kazuo
2012-10-01
To investigate the dose-dependent efficacy and safety of diquafosol ophthalmic solution for the treatment of dry eye syndrome. Randomized, double-masked, multicenter, parallel-group, placebo-controlled trial. A total of 286 Japanese patients with dry eye who were prescribed topical diquafosol (1%, n = 96; 3%, n = 96) or placebo ophthalmic solution (n = 94). After a washout period of 2 weeks, qualified subjects were randomized to receive a single drop of 1% or 3% diquafosol or placebo ophthalmic solutions 6 times per day for 6 weeks. The primary outcome measure was fluorescein corneal staining score assessment. The secondary outcome measures were Rose Bengal corneal and conjunctival staining scores, tear break-up time (BUT), and subjective symptom assessment. Safety measures were clinical blood and urine examination and recording of adverse events. Fluorescein corneal staining scores significantly improved with both 1% and 3% topical diquafosol compared with placebo at 4 weeks, respectively (P = 0.037, P = 0.002). There was a dose-dependent effect among the groups. Rose Bengal corneal and conjunctival staining scores also improved significantly with both 1% and 3% diquafosol compared with placebo (P = 0.007 and P = 0.004, respectively). Subjective dry eye symptom scores significantly improved with both diquafosol ophthalmic solutions (P ≤ 0.033), although there were no significant differences in BUT compared with placebo. No significant differences between the treatment groups were observed in relation to the occurrence of adverse events. Both 1% and 3% diquafosol ophthalmic solutions are considered effective and safe for the treatment of dry eye syndrome. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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Huang, Wenbin; Wang, Wei; Zhan, Jiao; Zhou, Minwen; Chen, Shida; Zhang, Xiulan
2013-06-26
Eye diseases with increasing mortality are common health problems that affect people of all ages and demographic backgrounds. In this study, we study the publication characteristics in international ophthalmic journals of the US, the UK, Germany, Australia, Japan, and China. Articles published in 53 ophthalmic journals from 2000 to 2011 were retrieved from the PubMed database. We recorded the number of articles published each year, analyzed the publication type, and evaluated the accumulated and average impact factors (IFs), and the distribution of articles in ophthalmic journals in relation to IFs. The characteristics of publication outputs from China and other top-ranking countries were compared. The total number of articles increased significantly during the past 12 years, with an increase of 51.0%. The growth in the annual number of articles from the US, the UK, Australia, and China showed a significantly positive trend. Publications from the US exceeded those from any other country and had the highest IFs, largest number of total citations of articles, and the most articles published in leading ophthalmic journals. During the past 12 years, China contributed 3.5% of the total publications, and the number of Chinese articles showed a more than 6-fold increase (from 99 to 605, R2 =0.947, P<0.001). The numbers of IFs and citations of articles originating in China were mostly lower than for other top-ranking counties. Research on ophthalmic journals has maintained an upward growing trend from 2000 to 2011. Chinese ophthalmology research has developed rapidly, but the gap still exists between China and other top-ranking countries for the advanced level of research.
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76 FR 35226 - National Institute on Drug Abuse; Notice of Closed Meetings
2011-06-16
...-402-6626, [email protected] . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse... Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel...
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77 FR 63846 - National Institute on Drug Abuse; Notice of Closed Meetings
2012-10-17
[email protected] . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction... Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis...
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Smart, Brian A
2009-01-01
The US Food and Drug Administration (FDA) has launched an investigation into the safety of long-acting beta(2)-agonists (LABAs). While the impact of this investigation is yet to be seen, clinicians should be circumspect in the use of these agents and prescribe them according to the recommendations of current asthma guidelines, informing patients and their caretakers about potential risks. As clinical trials attempt to address the question of whether LABAs are safe for use in pediatric and adult populations, current data provide no clear answers. A special hearing of the FDA's Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and Pediatric Advisory Committee attempted to seek consensus on the matter as it reviewed the results of controlled clinical trials and conducted a benefit:risk assessment of LABAs to make recommendations on their safety.
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Nam, Ki Tae; Ahn, So Min; Eom, Youngsub; Kim, Hyo Myung; Song, Jong Suk
2015-12-01
The purpose of this study was to evaluate the immediate effect of 3% diquafosol ophthalmic solution on tear break-up time (TBUT) in normal human eyes, and to compare it with that of saline and 0.1% hyaluronate ophthalmic solution. Cross sectional comparative study in the first study, 10 healthy volunteers underwent topical application of 2 different ophthalmic solutions in each eye. Saline was randomly applied to one eye and 3% diquafosol ophthalmic solution was added to the fellow eye. TBUT was measured and video recorded before application and at 5, 10, 15, and 20 min after. The TBUT in each eye was compared at each time point with regard to the 2 different ophthalmic solutions. In the second study, another 10 healthy volunteers were included. The same methods were used to compare the immediate effects of 0.1% hyaluronate and 3% diquafosol ophthalmic solution application on TBUT. In the first study, topical instillation of saline did not increase TBUT. However, 3% diquafosol significantly increased TBUT for up to 15 min after application. At every time point, the TBUT increased more significantly from baseline in the diquafosol group than it did in the saline group. In the second study, 0.1% hyaluronate increased TBUT for up to 5 min after application, while 3% diquafosol increased TBUT for up to 15 min. Although the TBUT changes after 5 min were not significantly different between the 2 groups, the TBUT changes at 10, 15, and 20 min were significantly greater in the 3% diquafosol group than they were in the 0.1% hyaluronic acid group (+1.58 ± 0.82 vs. +0.53 ± 1.36 at 10 min, +0.67 ± 0.91 vs. -0.04 ± 1.29 at 15 min, and -0.06 ± 0.96 vs. -0.59 ± 0.90, diquafosol group vs. hyaluronic acid group). One drop of 3% diquafosol increased TBUT for up to 15 min after application. The immediate effect of 3% diquafosol on TBUT was greater than that of saline and even that of 1% hyaluronate ophthalmic solution.
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2010-06-14
... a Public Meeting of the Science Advisory Board Exposure and Human Health Committee (EHHC) AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Science Advisory Board (SAB) Staff... Science Advisory Board can be found on the SAB Web site at http://www.epa.gov/sab . SUPPLEMENTARY...
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Application of ophthalmic ultrasonographyin DR
Directory of Open Access Journals (Sweden)
Ya-Ke Li
2018-02-01
Full Text Available AIM: To investigate the value of ultrasonography in diabetic retinopathy(DR. METHODS: Totally 103 cases(103 eyesof type 2 diabetes mellitus were selected from May 2015 to May 2017 in our hospital, there were 32 patients 32 eyes with non diabetic retinopathy(NDR, 40 patients 40 eyes with non proliferative diabetic retinopathy(NPDR, and 31 patients 31 eyes with proliferative diabetic retinopathy(PDR, 40 healthy volunteers(40 eyeswere selected as control group, the maximum systolic blood flow velocity(PSV, end diastolic velocity(EDVand resistance index(RIof the central retinal artery(CRA, posterior ciliary artery(PCAand ophthalmic artery(OAwere detected by color Doppler ultrasound. RESULTS: The difference of PSV, EDV and RI of CRA, PCA and OA in each group was statistically significant(PPPPCONCLUSION: Color Doppler ultrasound monitoring the hemodynamic changes of ocular blood vessels in diabetes can provide evidence for early detection of diabetic retinopathy.
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2011-07-08
... ENVIRONMENTAL PROTECTION AGENCY [FRL-9431-7] Science Advisory Board Staff Office; Notification of a Public Meeting of the Science Advisory Board Panel for the Review of Great Lakes Restoration... information concerning the EPA Science Advisory Board can be found at the EPA SAB Web site at http://www.epa...
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Neuro-ophthalmic and clinical characteristics of brain tumours in a tertiary hospital in Ghana
International Nuclear Information System (INIS)
Tagoe, N. N.; Essuman, V. A.; Fordjuor, G.; Akpalu, J.; Bankah, P.; Ndanu, T.
2015-01-01
Anecdotally, increasing number of patients are seen at Korle Bu Teaching Hospital (KBTH) with brain tumour. Neuro-ophthalmic symptoms and signs may help in timely diagnosis and intervention. The objective of this study is to evaluate the neuro-ophthalmic and clinical characteristics of brain tumour in patients presenting at a tertiary hospital in Ghana. The study design involved a prospective case series involving 36 consecutive patients newly diagnosed with brain tumour from November 2010 to October 2011, at the Ophthalmology, Neurosurgery and Endocrine units of KBTH, Ghana. All patients had clinical diagnosis of brain tumour with confirmation by computerized tomography (CT) or magnetic resonance imaging (MRI). Thirteen patients had histological confirmation of diagnosis. The outcome measures of the study include presenting visual acuity, colour vision, visual fields and cranial nerve deficits. Data of 36 patients were analysed. The results of the study showed that ages ranged from 3 to 69 years, mean (SD) 42.56(±16.6 years). Twenty-six (72%) were females. Tumours included pituitary adenoma (20, 55.5%), meningioma (10, 27.8%), choroid plexus tumour (1, 2.8%), medulloblastom (1, 2.8%), craniopharyngioma (1, 2.8%), haemangioblastoma (1, 2.8%), thalamic tumour (1, 2.8%) and haemangioma (1, 2.8%). Histologically confirmed tumours included pituitary adenoma (9, 69.2%), meningioma (3, 23.1%), craniopharyngioma (1, 7.7%). One patient had both a pituitary adenoma and meningioma. Blurred vision (30, 83.3%), headache (28, 77.8%) and photophobia (13, 36.1%) were predominant symptoms. Commonest neuro-ophthalmic signs were impaired colour vision (62 eyes, 88.6%), optic atrophy (26, 74.3%), unilateral or bitemporal hemianopia (15, 41.5%) and relative afferent pupillary defect (12, 34.3%). Seven (19.4%) patients were visually impaired and nine (25%) blind. Thirty-three of 72(45.8%) eyes had monocular blindness. Common neuro-ophthalmic characteristics were blurred vision
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Khan, Arif O; Aldahmesh, Mohammed A; Meyer, Brian
2008-04-01
To correlate ophthalmic findings with carrier status for a severe Norrie disease (ND) gene mutation (C95F). Prospective interventional case series. Six potential carriers and 1 obligate carrier from a family harboring the mutation. An ophthalmologist blind to the pedigree performed a full ophthalmic examination for the 7 asymptomatic family members. A peripheral blood sample was collected from each for ND gene sequencing. Ophthalmic examination findings (with attention to the presence or absence of retinal findings) and results of ND gene sequencing. Three carriers were identified by molecular genetics, and all 3 of them had peripheral retinal abnormality. However, 3 of the 4 genetically identified noncarriers also exhibited peripheral retinal abnormality. Two of these noncarriers with retinal findings were the offspring of a confirmed noncarrier. The genetically identified noncarrier with a normal peripheral retinal examination was the daughter of an obligate carrier. The presence of peripheral retinal changes was not useful for carrier prediction in a family harboring ND. There are likely additional loci responsible for phenotypic expression.
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Efficacy and safety of fixed-combination bimatoprost/timolol ophthalmic solution
Moon, Suk Bae; Han, Sang Beom
2017-01-01
Suk Bae Moon,1 Sang Beom Han21Department of Surgery, Kangwon National University Hospital, Kangwon National University Graduate School of Medicine, Chuncheon, Korea, 2Department of Ophthalmology, Kangwon National University Hospital, Kangwon National University Graduate School of Medicine, Chuncheon, KoreaWe read, with interest, the article by Sun et al1 entitled “Patient satisfaction with fixed-combination bimatoprost/timolol ophthalmic solution: a survey study in patients with gla...
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ITS Standards Advisory : Dynamic Message Signs (DMS)
2003-01-01
ITS Standards Advisories provide the transportation community with information and guidance on key activities related to ITS standards, with each Advisory focusing on a single ITS application and its corresponding standards. This advisory focuses on ...
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75 FR 17701 - High Energy Physics Advisory Panel
2010-04-07
... DEPARTMENT OF ENERGY High Energy Physics Advisory Panel AGENCY: Department of Energy, Office of... Physics Advisory Panel (HEPAP). Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires... Energy Physics Advisory Panel; U.S. Department of Energy; SC-25/ Germantown Building, 1000 Independence...
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2012-09-11
... Committee; Earth Science Subcommittee; Applied Sciences Advisory Group Meeting AGENCY: National Aeronautics... the Applied Science Advisory Group. This Subcommittee reports to the Earth Science Subcommittee... following topics: --Applied Sciences Program Update --Earth Science Data Latency Study Preliminary Update...
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76 FR 4928 - National Institute on Drug Abuse; Amended Notice of Meeting
2011-01-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Advisory Council on Drug Abuse, February 2, 2011, 8:30 a.m. to 2:45 p.m., National Institutes of Health...
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Ito, Tomokazu; Yamauchi, Ayako; Hemmi, Hisashi; Yoshimura, Tohru
2016-12-01
Escherichia coli YggS is a highly conserved pyridoxal 5'-phosphate (PLP)-binding protein whose biochemical function is currently unknown. A previous study with a yggS-deficient E. coli strain (ΔyggS) demonstrated that YggS controls l-Ile- and l-Val-metabolism by modulating 2-ketobutyrate (2-KB), l-2-aminobutyrate (l-2-AB), and/or coenzyme A (CoA) availability in a PLP-dependent fashion. In this study, we found that ΔyggS accumulates an unknown metabolite as judged by amino acid analyses. LC/MS and MS/MS analyses of the compound with propyl chloroformate derivatization, and co-chromatography analysis identified this compound as γ-l-glutamyl-l-2-aminobutyryl-glycine (ophthalmic acid), a glutathione (GSH) analogue in which the l-Cys moiety is replaced by l-2-AB. We also determine the metabolic consequence of the yggS mutation. Absence of YggS initially increases l-2-AB availability, and then causes ophthalmic acid accumulation and CoA limitation in the cell. The expression of a γ-glutamylcysteine synthetase and a glutathione synthetase in a ΔyggS background causes high-level accumulation of ophthalmic acid in the cells (∼1.2 nmol/mg cells) in a minimal synthetic medium. This opens the possibility of a first fermentative production of ophthalmic acid. Copyright © 2016 The Society for Biotechnology, Japan. Published by Elsevier B.V. All rights reserved.
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Uchiyama, Masaaki; Shimizu, Akira; Masuda, Yukinari; Nagasaka, Shinya; Fukuda, Yuh; Takahashi, Hiroshi
2013-01-01
We clarified the effects of an ophthalmic solution of a peroxisome proliferator-activated receptor gamma (PPARγ) agonist on corneal inflammation and wound healing after alkali burn injury in rats. After alkali exposure, either an ophthalmic solution with 0.1% pioglitazone hydrochloride (the PPARγ group) or vehicle (the vehicle group) was topically applied to the cornea until day 14. Histological, immunohistochemical, and real-time reverse transcription polymerase chain reaction analysis were performed. After alkali injury, PPARγ expression increased, with the infiltration of many inflammatory cells. The infiltration of neutrophils and macrophages started from the corneal limbus within 6 h, and developed in the corneal center by day 7, with associated neovascularization. The accumulation of α-smooth muscle actin-positive myofibroblasts and the deposition of type III collagen were noted on day 14. The histological changes were suppressed significantly by treatment with the ophthalmic solution of the PPARγ agonist. In addition, the number of infiltrating M2 macrophages in the cornea was increased by PPARγ agonist treatment. In real-time reverse transcription polymerase chain reaction analysis, the messenger ribonucleic acid expression levels of interleukin-1β (IL-1β), IL-6, IL-8, monocyte chemoattractant protein-1, tumor necrosis factor-α, transforming growth factor beta 1, and vascular endothelial growth factor-A were decreased in the PPARγ group compared to the vehicle group in the early periods of corneal inflammation. The ophthalmic solution of the PPARγ agonist inhibited inflammation, decreased the fibrotic reaction, and prevented neovascularization in the cornea from the early phase after alkali burn injury. The ophthalmic solution of the PPARγ agonist may provide a new treatment strategy with useful clinical applications for corneal inflammation and wound healing.
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Directory of Open Access Journals (Sweden)
Xianzhen Ma
2014-01-01
Full Text Available Purpose. The aim of this study was to investigate the effect of tea polyphenols (TP ophthalmic gel on lens epithelial cells (LECs in rabbits with silicone oil tamponade after vitrectomy. Methods. In this study, unilateral vitrectomy with silicone oil tamponade was performed using 2-month-old New Zealand white rabbits (n = 72; meanwhile, age-matched nonoperated rabbits (n = 18 were used as controls. The TP ophthalmic gel was administered topically in the surgical eyes till they were sacrificed. On days 45 and 90 after operation, the levels of reactive oxygen species (ROS, mitochondrial membrane potential (ΔΨm, and apoptosis of LECs were analyzed, respectively. Meanwhile, caspase-3 mRNA and protein levels were also determined. Results. The results indicate that the levels of ROS and apoptosis were elevated for LECs in rabbits after operation, whereas ΔΨm was decreased. Caspase-3 was apparently increased at both mRNA and protein levels. Treatment of TP ophthalmic gel could reduce the generation of ROS, maintain ΔΨm, inhibit the overexpression of caspase-3, and thus decrease the apoptosis of LECs of rabbits after operation. Conclusions. TP ophthalmic gel can efficiently inhibit caspase-3 overexpression, reduce the apoptosis of LECs, and prevent LECs from damage. Our result provides a new approach to prevent the development of complicated cataract after vitrectomy.
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Beach Advisory and Closing Online Notification (BEACON) system
Beach Advisory and Closing Online Notification system (BEACON) is a colletion of state and local data reported to EPA about beach closings and advisories. BEACON is the public-facing query of the Program tracking, Beach Advisories, Water quality standards, and Nutrients database (PRAWN) which tracks beach closing and advisory information.
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76 FR 21877 - Environmental Management Advisory Board
2011-04-19
... DEPARTMENT OF ENERGY Environmental Management Advisory Board AGENCY: Department of Energy. ACTION: Notice of call for nominations for appointment to the Environmental Management Advisory Board. SUMMARY... Environmental Management Advisory Board. DATES: Nominations will be accepted through May 13, 2011. ADDRESSES...
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77 FR 19300 - National Infrastructure Advisory Council
2012-03-30
... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2012-0012] National Infrastructure Advisory... an open Federal Advisory Committee meeting. SUMMARY: The National Infrastructure Advisory Council... business. For additional information, please consult the NIAC Web site, www.dhs.gov/NIAC , or contact the...
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2013-03-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2012-04-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2011-03-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2011-10-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...
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2011-10-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2010-08-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2013-05-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2011-07-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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In situ gel systems as 'smart' carriers for sustained ocular drug delivery.
Agrawal, Ashish Kumar; Das, Manasmita; Jain, Sanyog
2012-04-01
In situ gel systems refer to a class of novel delivery vehicles, composed of natural, semisynthetic or synthetic polymers, which present the unique property of sol-gel conversion on receipt of biological stimulus. The present review summarizes the latest developments in in situ gel technology, with regard to ophthalmic drug delivery. Starting with the mechanism of ocular absorption, the review expands on the fabrication of various polymeric in situ gel systems, made up of two or more polymers presenting multi-stimuli sensitivity, coupled with other interesting features, such as bio-adhesion, enhanced penetration or sustained release. Various key issues and challenges in this area have been addressed and critically analyzed. The advent of in situ gel systems has inaugurated a new transom for 'smart' ocular delivery. By virtue of possessing stimuli-responsive phase transition properties, these systems can easily be administered into the eye, similar to normal eye drops. Their unique gelling properties endow them with special features, such as prolonged retention at the site of administration, followed by sustained drug release. Despite the superiority of these systems as compared with conventional ophthalmic formulations, further investigations are necessary to address the toxicity issues, so as to minimize regulatory hurdles during commercialization.
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Numerical Modeling of Ophthalmic Response to Space
Nelson, E. S.; Myers, J. G.; Mulugeta, L.; Vera, J.; Raykin, J.; Feola, A.; Gleason, R.; Samuels, B.; Ethier, C. R.
2015-01-01
To investigate ophthalmic changes in spaceflight, we would like to predict the impact of blood dysregulation and elevated intracranial pressure (ICP) on Intraocular Pressure (IOP). Unlike other physiological systems, there are very few lumped parameter models of the eye. The eye model described here is novel in its inclusion of the human choroid and retrobulbar subarachnoid space (rSAS), which are key elements in investigating the impact of increased ICP and ocular blood volume. Some ingenuity was required in modeling the blood and rSAS compartments due to the lack of quantitative data on essential hydrodynamic quantities, such as net choroidal volume and blood flowrate, inlet and exit pressures, and material properties, such as compliances between compartments.
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New Drug Reimbursement and Pricing Policy in Taiwan.
Chen, Gau-Tzu; Chang, Shu-Chen; Chang, Chee-Jen
2018-05-01
Taiwan has implemented a national health insurance system for more than 20 years now. The benefits of pharmaceutical products and new drug reimbursement scheme are determined by the Expert Advisory Meeting and the Pharmaceutical Benefit and Reimbursement Scheme (PBRS) Joint Committee in Taiwan. To depict the pharmaceutical benefits and reimbursement scheme for new drugs and the role of health technology assessment (HTA) in drug policy in Taiwan. All data were collected from the Expert Advisory Meeting and the PBRS meeting minutes; new drug applications with HTA reports were derived from the National Health Insurance Administration Web site. Descriptive statistics were used to analyze the timeline of a new drug from application submission to reimbursement effective, the distribution of approved price, and the approval rate for a new drug with/without local pharmacoeconomic study. After the second-generation national health insurance system, the timeline for a new drug from submission to reimbursement effective averages at 436 days, and that for an oncology drug reaches an average of 742 days. New drug approval rate is 67% and the effective rate (through the approval of the PBRS Joint Committee and the acceptance of the manufacturer) is 53%. The final approved price is 53.6% of the international median price and 70% of the proposed price by the manufacturer. Out of 95 HTA reports released during the period January 2011 to February 2017, 28 applications (30%) conducted an HTA with a local pharmacoeconomic study, and all (100%) received reimbursement approval. For the remaining 67 applications (70%) for which HTA was conducted without a local pharmacoeconomic analysis, 54 cases (81%) were reimbursed. New drug applications with local pharmacoeconomic studies are more likely to get reimbursement. Copyright © 2018. Published by Elsevier Inc.
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Salomone, Salvatore; Foresti, Roberta; Villari, Ambra; Giurdanella, Giovanni; Drago, Filippo; Bucolo, Claudio
2014-12-15
Nitric oxide (NO), carbon monoxide (CO) and hydrogen sulphide (H2S) modulate vascular tone. In view of their therapeutic potential for ocular diseases, we examined the effect of exogenous CO and H2S on tone of isolated rabbit ophthalmic artery and their interaction with endogenous and exogenous NO. Ophthalmic artery segments mounted on a wire myograph were challenged with cumulative concentrations of phenylephrine (PE) in the presence or absence of NG-nitro-L-arginine (LNNA) to inhibit production of NO, the CO-releasing molecules CORMs or the H2S-donor GYY4137. The maximal vasoconstriction elicited by PE reached 20-30% of that induced by KCl but was dramatically increased by incubation with LNNA. GYY4137 significantly raised PE-mediated vasoconstriction, but it did not change the response to PE in the presence of LNNA or the relaxation to sodium nitroprusside (SNP). CORMs concentration-dependently inhibited PE-induced constriction, an effect that was synergistic with endogenous NO (reduced by LNNA), but insensitive to blockade of guanylyl cyclase by 1H-[1,2,4]oxadiazolo[4,3,-α]quinoxalin-1-one (ODQ). In vascular tissues cyclic GMP (cGMP) levels seemed reduced by GYY4137 (not significantly), but were not changed by CORM. These data indicate that CO is able per se to relax isolated ophthalmic artery and to synergize with NO, while H2S counteracts the effect of endogenous NO. CO does not stimulate cGMP production in our system, while H2S may reduce cGMP production stimulated by endogenous NO. These findings provide new insights into the complexities of gas interactions in the control of ophthalmic vascular tone, highlighting potential pharmacological targets for ocular diseases. Copyright © 2014 Elsevier Inc. All rights reserved.
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2011-03-09
....gov . Submit written comments to the Division of Dockets Management, Food and Drug Administration... be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday... telephone number is 301- 589-5200. Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and Research...
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Leeburg, Kelsey C.; El-Haddad, Mohamed T.; Malone, Joseph D.; Terrones, Benjamin D.; Tao, Yuankai K.
2018-02-01
Scanning laser ophthalmoscopy (SLO) provides high-speed, noninvasive en face imaging of the retinal fundus. Optical coherence tomography (OCT) is the current "gold-standard" for ophthalmic diagnostic imaging and enables depth-resolved visualization of ophthalmic structures and image-based surrogate biomarkers of disease. We present a compact optical and mechanical design for handheld spectrally encoded coherence tomography and reflectometry (SECTR) for multimodality en face spectrally encoded reflectometry (SER) and cross-sectional OCT imaging. We custom-designed a double-pass telecentric scan lens, which halves the size of 4-f optical relays and allowed us to reduce the footprint of our SECTR scan-head by a factor of >2.7x (volume) over our previous design. The double-pass scan lens was optimized for diffraction-limited performance over a +/-10° scan field. SECTR optics and optomechanics were combined in a compact rapid-prototyped enclosure with dimensions 87 x 141.8 x 137 mm (w x h x d). SECTR was implemented using a custom-built 400 kHz 1050 nm swept-source. OCT and SER were simultaneously digitized on dual input channels of a 4 GS/s digitizer at 1.4 GS/s per channel. In vivo human en face SER and cross-sectional OCT images were acquired at 350 fps. OCT volumes of 1000 B-scans were acquired in 2.86 s. We believe clinical translation of our compact handheld design will benefit point-of-care ophthalmic diagnostics in patients who are unable to be imaged on conventional slit-lamp based systems, such as infants and the bedridden. When combined with multi-volumetric registration methods, handheld SECTR will have advantages in motion-artifact free imaging over existing handheld technologies.
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Palte, Howard D; Gayer, Steven; Arrieta, Esdras; Scot Shaw, Eric; Nose, Izuru; Lee, Elizabete; Arheart, Kristopher L; Dubovy, Sander; Birnbach, David J; Parel, Jean-Marie
2012-07-01
Since Atkinson's original description of retrobulbar block in 1936, needle-based anesthetic techniques have become integral to ophthalmic anesthesia. These techniques are unfortunately associated with rare, grave complications such as globe perforation. Ultrasound has gained widespread acceptance for peripheral nerve blockade, but its translation to ocular anesthesia has been hampered because sonic energy, in the guise of thermal or biomechanical insult, is potentially injurious to vulnerable eye tissue. The US Food and Drug Administration (FDA) has defined guidelines for safe use of ultrasound for ophthalmic examination, but most ultrasound devices used by anesthesiologists are not FDA-approved for ocular application because they generate excessive energy. Regulating agencies state that ultrasound examinations can be safely undertaken as long as tissue temperatures do not increase >1.5°C above physiological levels. Using a rabbit model, we investigated the thermal and mechanical ocular effects after prolonged ultrasonic exposure to single orbital- and nonorbital-rated devices. In a dual-phase study, aimed at detecting ocular injury, the eyes of 8 rabbits were exposed to continuous 10-minute ultrasound examinations from 2 devices: (1) the Sonosite Micromaxx (nonorbital rated) and (2) the Sonomed VuMax (orbital rated) machines. In phase I, temperatures were continuously monitored via thermocouples implanted within specific eye structures (n = 4). In phase II the eyes were subjected to ultrasonic exposure without surgical intervention (n = 4). All eyes underwent light microscopy examinations, followed at different intervals by histology evaluations conducted by an ophthalmic pathologist. Temperature changes were monitored in the eyes of 4 rabbits. The nonorbital-rated transducer produced increases in ocular tissue temperature that surpassed the safe limit (increases >1.5°C) in the lens of 3 rabbits (at 5.0, 5.5, and 1.5 minutes) and cornea of 2 rabbits (both at 1
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Ocular surface distribution and pharmacokinetics of a novel ophthalmic 1% azithromycin formulation.
Akpek, Esen Karamursel; Vittitow, Jason; Verhoeven, Rozemarijn S; Brubaker, Kurt; Amar, Thierry; Powell, Kendall D; Boyer, José L; Crean, Christopher
2009-10-01
To investigate the ocular distribution of 1% azithromycin ophthalmic solution and the effect of polycarbophil-based mucoadhesive formulation on ocular tissue levels of azithromycin after single and multiple topical administrations in the rabbit eye. Rabbits were treated with either a single administration of 1% azithromycin solution with or without polycarbophil, or with multiple administrations of 1% azithromycin solution in polycarbophil. Drug concentrations were measured using LC/MS/MS. Conjunctiva, cornea, aqueous humor, and tear samples were analyzed over a period of 144 h after a single administration of azithromycin with or without polycarbophil. Eyelid, conjunctiva, cornea, aqueous humor, and tear samples were collected over a period of 288 h during and after multiple administrations of azithromycin. Azithromycin was rapidly absorbed and distributed in the ocular tissues, reaching within 5 min, concentrations of 10,539 microg/mL in tear film, 108 microg/g in conjunctiva, and 40 microg/g in the cornea. The drug demonstrated tissue-specific half-lives of 15, 63, and 67 h, respectively. Following multiple administrations, the drug gradually accumulated. The polycarbophil formulation increased the bioavailability of the drug, producing peak concentrations that were between 5- and 12-fold higher than those without polycarbophil. Azithromycin also distributed rapidly in the eyelids, reaching peak concentrations of 180 mug/g at the end of the 7-day treatment, and was eliminated with a half-life of 125 h. Six days after treatment was discontinued, eyelid levels of azithromycin were above 40 microg/g. Sustained and high concentrations were encountered with 7-day approved administration of 1% azithromycin formulation (AzaSite, Inspire Pharmaceuticals, Inc., Durham, NC) within all ocular surface tissues, particularly the lids. Many ocular surface disorders involving the tear film, eyelids, and adnexal structures are associated with chronic, low-grade bacterial
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2012-03-02
... for the implementation of best business practices to improve Federal Government management and... performance management, Senior Executive Service (SES) leadership development and SES performance appraisal... President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting AGENCY...
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2010-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...
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78 FR 40487 - National Infrastructure Advisory Council
2013-07-05
... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2013-0033] National Infrastructure Advisory... an open Federal Advisory Committee Meeting. SUMMARY: The National Infrastructure Advisory Council..., from 1:30 p.m. to 4:30 p.m. The meeting may close early if the committee has completed its business...
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Jin, Sang Wook; Min, Ji Sang
2016-05-01
To investigate the effects of diquafosol on intraocular pressure (IOP) and dry eye symptoms in glaucoma patients with dry eye syndrome (DES). This study evaluated a total of 138 glaucoma patients with DES who were treated with diquafosol ophthalmic solution (DIQUAS(®)). Before treatment and 1, 4, 12, 36, and 52 weeks after treatment, IOP, ocular surface disease index (OSDI), tear film break-up time (BUT), Schirmer I test scores, fluorescein staining, conjunctival impression cytology, and adverse drug reactions were evaluated. Throughout the treatment period, the mean IOP for all the patients remained stable after treatment with diquafosol (15.4 ± 2.8 mmHg at baseline and 16.0 ± 2.8 mmHg at 52 weeks). The mean OSDI score improved significantly at 4, 12, and 52 weeks after diquafosol treatment. The BUT and Schirmer I test scores were significantly increased after diquafosol treatment. The Oxford scheme score was significantly decreased at 1, 4, 12, 36, and 52 weeks after diquafosol treatment. A significant improvement in goblet cell density was observed after 4 weeks of treatment with diquafosol. Adverse drug reactions were reported in 22 (15.9 %) patients. There were no serious adverse drug reactions. Diquafosol was effective in improving objective and subjective symptoms and maintained a stable IOP in glaucoma patients with DES. Therefore, the addition of diquafosol treatment in glaucoma patients with DES or ocular surface side effects using anti-glaucoma medication may be beneficial.
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2012-06-26
... for the implementation of best business practices to improve Federal Government management and... management, IT vendor performance management, Senior Executive Service (SES) leadership development and SES... President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting AGENCY...
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Dosimetry of Sr-90 ophthalmic applicators
International Nuclear Information System (INIS)
Reft, C.S.; Kuchnir, F.T.; Rosenberg, I.; Myrianthopoulos, L.C.
1990-01-01
Sr-90 ophthalmic applicators are commonly used for the treatment of superficial eye disorders. Although a variety of dosimetric devices such as film, thermoluminescent dosimeters (TLD's), ion chambers, and radiochromic foils have been used to measure the peak dose at the applicator surface, there is no internationally agreed upon calibration procedure. Recently, large discrepancies among calibrations of the same applicator at three institutions have been reported. Here we describe a technique to obtain the peak dose rate at the applicator surface using LiF TLD's. The technique can be used for the calibration of flat as well as curved surface applicators. Results for two flat and three concave applicators are presented. Our measurement of the surface dose rate for one of the flat applicators is compared with those obtained by four other institutions, each using different dosimetric devices
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Uchiyama, Masaaki; Masuda, Yukinari; Nagasaka, Shinya; Fukuda, Yuh; Takahashi, Hiroshi
2013-01-01
Purpose We clarified the effects of an ophthalmic solution of a peroxisome proliferator-activated receptor gamma (PPARγ) agonist on corneal inflammation and wound healing after alkali burn injury in rats. Methods After alkali exposure, either an ophthalmic solution with 0.1% pioglitazone hydrochloride (the PPARγ group) or vehicle (the vehicle group) was topically applied to the cornea until day 14. Histological, immunohistochemical, and real-time reverse transcription polymerase chain reaction analysis were performed. Results After alkali injury, PPARγ expression increased, with the infiltration of many inflammatory cells. The infiltration of neutrophils and macrophages started from the corneal limbus within 6 h, and developed in the corneal center by day 7, with associated neovascularization. The accumulation of α-smooth muscle actin-positive myofibroblasts and the deposition of type III collagen were noted on day 14. The histological changes were suppressed significantly by treatment with the ophthalmic solution of the PPARγ agonist. In addition, the number of infiltrating M2 macrophages in the cornea was increased by PPARγ agonist treatment. In real-time reverse transcription polymerase chain reaction analysis, the messenger ribonucleic acid expression levels of interleukin-1β (IL-1β), IL-6, IL-8, monocyte chemoattractant protein-1, tumor necrosis factor-α, transforming growth factor beta 1, and vascular endothelial growth factor-A were decreased in the PPARγ group compared to the vehicle group in the early periods of corneal inflammation. Conclusions The ophthalmic solution of the PPARγ agonist inhibited inflammation, decreased the fibrotic reaction, and prevented neovascularization in the cornea from the early phase after alkali burn injury. The ophthalmic solution of the PPARγ agonist may provide a new treatment strategy with useful clinical applications for corneal inflammation and wound healing. PMID:24194635
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2011-10-17
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-095)] NASA Advisory Committee; Renewal of NASA's International Space Station Advisory Committee Charter AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the Charter of the International...
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2012-01-19
... Business Enterprise: Meeting of the National Advisory Council on Minority Business Enterprise AGENCY.... SUMMARY: The National Advisory Council for Minority Business Enterprise (NACMBE) will hold its fifth... deliberate on possible recommendations. The Subcommittee topics include: (1) Definition of Minority Business...
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Wong, Carlos King Ho; Wu, Olivia; Cheung, Bernard M Y
2018-02-01
The aim of this article is to describe the process, evaluation criteria, and possible outcomes of decision-making for new drugs listed in the Hong Kong Hospital Authority Drug Formulary in comparison to the health technology assessment (HTA) policy overseas. Details of decision-making processes including the new drug listing submission, Drug Advisory Committee (DAC) meeting, and procedures prior to and following the meeting, were extracted from the official Hong Kong Hospital Authority drug formulary management website and manual. Publicly-available information related to the new drug decision-making process for five HTA agencies [the National Institute of Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the Australia Pharmaceutical Benefits Advisory Committee (PBAC), the Canadian Agency for Drugs and Technologies in Health (CADTH), and the New Zealand Pharmaceutical Management Agency (PHARMAC)] were reviewed and retrieved from official documents from public domains. The DAC is in charge of systemically and critically appraising new drugs before they are listed on the formulary, reviewing submitted applications, and making the decision to list the drug based on scientific evidence to which safety, efficacy, and cost-effectiveness are the primary considerations. When compared with other HTA agencies, transparency of the decision-making process of the DAC, the relevance of clinical and health economic evidence, and the lack of health economic and methodological input of submissions are the major challenges to the new-drug listing policy in Hong Kong. Despite these challenges, this review provides suggestions for the establishment of a more transparent, credible, and evidence-based decision-making process in the Hong Kong Hospital Authority Drug Formulary. Proposals for improvement in the listing of new drugs in the formulary should be a priority of healthcare reforms.
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An historical ophthalmic study of Jane Austen.
Wilson, Graham A
2012-11-01
Today, no other classic novelist has the popularity or power of Jane Austen, and in 2013 the world will celebrate 200 years of her comic masterpiece Pride and Prejudice. Her millions of fans have an abiding fascination with all aspects of her life, including her health and the cause of her death. This historical ophthalmic study of Jane Austen, based on very incomplete medical bibliographic data, finds that she had a mild ocular surface disorder from age 23. This disorder did not significantly impact on her visual performance for writing. There are many references to eyes in her novels, but Jane's eyes and those of her characters cannot contribute further to the debate around the cause of her death at age 41.
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Jeong, Won Ju; Kim, Woon Young; Moon, Man Gook; Min, Doo Jae; Lee, Yoon Sook; Kim, Jae Hwan; Park, Young Cheol
2012-01-01
Background Emergence agitation (EA) frequently occurs after desflurane anesthesia in children. Ketamine, because of its sedative and analgesic properties, might be useful for the management of separation anxiety and EA. We investigated the preventive effect of ketamine on separation anxiety and EA after desflurane anesthesia in children for brief ophthalmic surgery. Methods Sixty children, ranging in age from 2-8 years old, undergoing brief ophthalmic surgery were randomly allocated to one of...
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42 CFR 90.9 - Public health advisory.
2010-10-01
... 42 Public Health 1 2010-10-01 2010-10-01 false Public health advisory. 90.9 Section 90.9 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES HEALTH ASSESSMENTS AND HEALTH... PROCEDURES § 90.9 Public health advisory. ATSDR may issue a public health advisory based on the findings of a...
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76 FR 62455 - Aerospace Safety Advisory Panel; Meeting
2011-10-07
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-088)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel... Burch, Aerospace Safety Advisory Panel Administrative Officer, National Aeronautics and Space...
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78 FR 1265 - Aerospace Safety Advisory Panel; Meeting
2013-01-08
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-001] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel..., Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space Administration...
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Toshida, Hiroshi; Funaki, Toshinari; Ono, Koichi; Tabuchi, Nobuhito; Watanabe, Sota; Seki, Tamotsu; Otake, Hiroshi; Kato, Takuji; Ebihara, Nobuyuki; Murakami, Akira
2017-01-01
The purpose of this study was to investigate the efficacy and safety of the administration of retinol palmitate (VApal) ophthalmic solution (500 IU/mL) for the treatment of patients with dry eye. This study included 66 patients with dry eye. After a 2-week washout period, patients were randomized (1:1) into either a VApal ophthalmic solution or a placebo group, and a single drop of either solution was administered six times daily for 4 weeks. Efficacy measures were 12 subjective symptoms, rose bengal (RB) and fluorescein staining scores, tear film breakup time, and tear secretion. Safety measures included clinical blood and urine analyses and adverse event recordings. In comparisons of the two groups, the mean change in RB staining score from baseline was significantly lower in the VApal group at 2 and 4 weeks ( P ophthalmic solution (500 IU/mL) is safe and effective for the treatment of patients with dry eye.
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76 FR 19147 - Aerospace Safety Advisory Panel; Meeting.
2011-04-06
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-030)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel.... Kathy Dakon, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...
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78 FR 56941 - Aerospace Safety Advisory Panel; Meeting
2013-09-16
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-114] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...
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77 FR 25502 - Aerospace Safety Advisory Panel; Meeting
2012-04-30
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-030)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel... FURTHER INFORMATION CONTACT: Ms. Harmony Myers, Aerospace Safety Advisory Panel Executive Director...
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77 FR 38090 - Aerospace Safety Advisory Panel; Meeting.
2012-06-26
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-044] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...
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75 FR 61219 - Aerospace Safety Advisory Panel; Meeting
2010-10-04
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-116)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel... Dakon, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space Administration...
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77 FR 58413 - Aerospace Safety Advisory Panel; Meeting
2012-09-20
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-074] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...
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2011-10-18
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...
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2012-09-17
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...
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2012-02-07
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...
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2013-04-10
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...
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75 FR 6407 - Aerospace Safety Advisory Panel; Meeting
2010-02-09
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10- 020)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel... FURTHER INFORMATION CONTACT: Ms. Kathy Dakon, Aerospace Safety Advisory Panel Executive Director, National...