Control of ocular inflammation after cataract extraction with rimexolone 1% ophthalmic suspension.

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.