CONTROL OF OCULAR INFLAMMATION AFTER CATARACT-EXTRACTION WITH RIMEXOLONE 1-PERCENT OPHTHALMIC SUSPENSION

Purpose: To assess the efficacy and safety of rimexolone 1% ophthalmic suspension in controlling intraocular inflammation after cataract ext raction. Setting: Twelve independent investigational centers in the Un ited States. Methods: This study comprised 197 patients who had catara ct extraction. Postoperatively, patients were randomized to a 2 week r egimen of rimexolone 1% ophthalmic suspension or a placebo. Efficacy w as analyzed by monitoring total anterior chamber cells and flare, othe r parameters of inflammation, and treatment failures. Safety was evalu ated by monitoring treatment-related adverse events and intraocular pr essure (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 even ts was 5.3% in the rimexolone group and 22.2% in the placebo group. Th ere 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 extr action when used four times daily and continued for 2 weeks.