Journal of cataract and refractive surgery · 1997
Control of ocular inflammation after cataract extraction with rimexolone 1% ophthalmic suspension.
Клиническое исследованиеСравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Assil K K, Massry G, Lehmann R, Fox K, Stewart R
Аннотация
PURPOSE: To assess the efficacy and safety of rimexolone 1% ophthalmic suspension in controlling intraocular inflammation after cataract extraction.
SETTING: Twelve independent investigational centers in the United States
METHODS: This study comprised 197 patients who had cataract extraction. Postoperatively, patients were randomized to a 2 week regimen of rimexolone 1% ophthalmic suspension or a placebo. Efficacy was analyzed by monitoring total anterior chamber cells and flare, other parameters of inflammation, and treatment failures. Safety was evaluated by monitoring treatment-related adverse events and intraocular pressure (IOP).
RESULTS: Rimexolone 1% was clinically and statistically more effective in suppressing cell and flare than the placebo (P < .02). The overall discontinuation rate for treatment-related adverse events was 5.3% in the rimexolone group and 22.2% in the placebo group. There were no between-group differences in IOP.
CONCLUSION: Rimexolone 1% ophthalmic suspension was safe and significantly more effective than a placebo in controlling intraocular inflammation after cataract extraction when used four times daily and continued for 2 weeks.
SETTING: Twelve independent investigational centers in the United States
METHODS: This study comprised 197 patients who had cataract extraction. Postoperatively, patients were randomized to a 2 week regimen of rimexolone 1% ophthalmic suspension or a placebo. Efficacy was analyzed by monitoring total anterior chamber cells and flare, other parameters of inflammation, and treatment failures. Safety was evaluated by monitoring treatment-related adverse events and intraocular pressure (IOP).
RESULTS: Rimexolone 1% was clinically and statistically more effective in suppressing cell and flare than the placebo (P < .02). The overall discontinuation rate for treatment-related adverse events was 5.3% in the rimexolone group and 22.2% in the placebo group. There were no between-group differences in IOP.
CONCLUSION: Rimexolone 1% ophthalmic suspension was safe and significantly more effective than a placebo in controlling intraocular inflammation after cataract extraction when used four times daily and continued for 2 weeks.