Control of ocular inflammation after cataract extraction with rimexolone 1% ophthalmic suspension.
OBJECTIVE
To assess the efficacy and safety of rimexolone 1% ophthalmic suspension in controlling intraocular inflammation after cataract extraction.


METHODS
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.


CONCLUSIONS
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.
Assil
K K
KK
Sinskey Eye Institute, Santa Monica, California 90411-0031, USA.
Massry
G
G
Lehmann
R
R
Fox
K
K
Stewart
R
R
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D009877:Endophthalmitis / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D018918:Phacoemulsification / Q000009:adverse effects*; D011245:Pregnadienes / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012449:Safety; D013535:Suspensions; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D009883:Ophthalmic Solutions; D011245:Pregnadienes; D013535:Suspensions; C013769:rimexolone