The Incidence of Macular Edema From Two Integrated Phase III Clinical Trials of Bromfenac Ophthalmic Solution Administered Once Daily for Cataract Surgery

Abstract

Purpose: : To evaluate the incidence of macular edema in a clinical study of bromfenac ophthalmic solution administered once daily for the prevention and treatment of anterior chamber inflammation associated with cataract surgery.

Methods: : Subjects were assigned randomly to receive either bromfenac ophthalmic solution QD (n=354) or placebo QD (n=179). Dosing began 1 day before cataract surgery and continued through post-surgery Day 14. The incidence of macular edema was assessed over the duration of the treatment (16 days) and follow-up (6 days) periods.

Results: : In the bromfenac treatment group, no subject (0%, 0/354) experienced an adverse event reported as macular edema. In the placebo treatment group, 4.5% (8/179) experienced the adverse event of macular edema. The severity of macular edema ranged from mild to severe; 5 subjects had macular edema ongoing at study completion, and in the 3 remaining subjects, the macular edema resolved at study termination.

Conclusions: : Bromfenac ophthalmic solution administered once daily may prevent and treat macular edema associated with cataract extraction surgery.

Clinical Trial: : www.clinicaltrials.gov NCT00333918

Keywords: cataract • macula/fovea • edema