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T. R. Walters, Y. R. Chu, E. R. Craven, L. R. DeBarge, L. Cacioppo, C. K. Song, R. Bianca, J. A. Gow, T. R. McNamara, Bromfenac Ophthalmic Solution Once Daily Study Group; The Incidence of Macular Edema From Two Integrated Phase III Clinical Trials of Bromfenac Ophthalmic Solution Administered Once Daily for Cataract Surgery. Invest. Ophthalmol. Vis. Sci. 2008;49(13):2705.
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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.
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.
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.
Bromfenac ophthalmic solution administered once daily may prevent and treat macular edema associated with cataract extraction surgery.
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