Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2007
The systemic safety of bromfenac ophthalmic solution 0.09%.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Stewart Robert H, Grillone Lisa R, Shiffman Mitchell L, Donnenfeld Eric D, Gow James A, Bromfenac Ophthalmic Solution 0.09% Study Group
Аннотация
STUDY OBJECTIVE: The aim of this study was to evaluate the systemic safety of a commercially available bromfenac ophthalmic solution 0.09% for the treatment of postoperative inflammation and reduction of ocular pain in subjects who have undergone cataract extraction.
DESIGN: Two phase III, multicenter, randomized, double-masked, parallel, placebo-controlled, clinical trials were conducted under a common protocol. These data were pooled for analysis.
SETTING: The setting for this study was a series of multicentered, private, and university-affiliated ophthalmology clinics in the United States.
SUBJECTS: A total of 527 subjects were sequentially assigned, according to a computer-generated randomization list (2:1) to either bromfenac (n = 356) or placebo (n = 171). Potential subjects were excluded if using nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, anticoagulants, or with uncontrolled ocular or systemic disease, preexisting ocular inflammation, surgical complications, or liver chemistry values of > or =Grade 1 according to World Health Organization Common Toxicity Criteria scoring.
INTERVENTION: Subjects who underwent cataract surgery without prior anti-inflammatory treatment and had a postsurgical Summed Ocular Inflammation Score (SOIS) of > or =3 were treated with either bromfenac or placebo. Subjects self-instilled 1 drop of the assigned test agent twice-daily for 14 days and were followed for an additional 14 days for safety evaluation.
MAIN OUTCOME MEASURES: Safety data were collected and the results for systemic safety are reported in this paper.
RESULTS: Five hundred and twenty-seven (527) subjects comprised the safety population. A total of 290 of 356 bromfenac and 93 of 171 placebo subjects received 28 doses of test agent. No clinically significant treatment-related systemic adverse effects or changes in liver chemistries were observed.
CONCLUSIONS: Bromfenac ophthalmic solution 0.09% demonstrated neither treatment-related systemic adverse events nor evidence of hepatic toxicity.
DESIGN: Two phase III, multicenter, randomized, double-masked, parallel, placebo-controlled, clinical trials were conducted under a common protocol. These data were pooled for analysis.
SETTING: The setting for this study was a series of multicentered, private, and university-affiliated ophthalmology clinics in the United States.
SUBJECTS: A total of 527 subjects were sequentially assigned, according to a computer-generated randomization list (2:1) to either bromfenac (n = 356) or placebo (n = 171). Potential subjects were excluded if using nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, anticoagulants, or with uncontrolled ocular or systemic disease, preexisting ocular inflammation, surgical complications, or liver chemistry values of > or =Grade 1 according to World Health Organization Common Toxicity Criteria scoring.
INTERVENTION: Subjects who underwent cataract surgery without prior anti-inflammatory treatment and had a postsurgical Summed Ocular Inflammation Score (SOIS) of > or =3 were treated with either bromfenac or placebo. Subjects self-instilled 1 drop of the assigned test agent twice-daily for 14 days and were followed for an additional 14 days for safety evaluation.
MAIN OUTCOME MEASURES: Safety data were collected and the results for systemic safety are reported in this paper.
RESULTS: Five hundred and twenty-seven (527) subjects comprised the safety population. A total of 290 of 356 bromfenac and 93 of 171 placebo subjects received 28 doses of test agent. No clinically significant treatment-related systemic adverse effects or changes in liver chemistries were observed.
CONCLUSIONS: Bromfenac ophthalmic solution 0.09% demonstrated neither treatment-related systemic adverse events nor evidence of hepatic toxicity.
Предметные рубрики MeSH
AgedAnterior Eye SegmentBenzophenonesBromobenzenesCataract ExtractionDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHumansInstillation, DrugIntraocular PressureLens Implantation, IntraocularLiver Function TestsMaleOphthalmic SolutionsPostoperative PainPhacoemulsificationPlacebosSelf AdministrationTreatment OutcomeVisual Acuity