Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.

Author(s): Korenfeld MS, Silverstein SM, Cooke DL, Vogel R, Crockett RS, Difluprednate Ophthalmic Emulsion 0.05% (Durezol) Study Group

Affiliation(s): Comprehensive Eye Care Ltd., 901 East 3rd Street, Washington, Missouri 63090, USA. michaelkorenfeld@hotmail.com

Publication date & source: 2009-01, J Cataract Refract Surg., 35(1):26-34.

Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

PURPOSE: To assess the efficacy and safety of difluprednate ophthalmic emulsion 0.05% (Durezol) 2 or 4 times a day compared with those of a placebo in the treatment of inflammation and pain associated with ocular surgery. SETTING: Twenty-six clinics in the United States. METHODS: One day after unilateral ocular surgery, patients who had an anterior chamber cell grade of 2 or higher (>10 cells) were treated with 1 drop of difluprednate 2 times or 4 times a day or with a placebo (vehicle) 2 times or 4 times a day in the study eye for 14 days. This was followed by a 14-day tapering period and a 7-day safety evaluation. Outcome measures included cleared anterior chamber inflammation (grade 0, <or=1 cell), absence of pain, and analysis of ocular adverse events. RESULTS: Of the 438 patients, 111 received difluprednate 2 times a day, 107 received difluprednate 4 times a day, and 220 received a placebo 2 or 4 times a day. Both difluprednate dosage regimens reduced postoperative ocular inflammation and pain safely and effectively compared with the placebo. A greater proportion of difluprednate-treated patients had a reduction in inflammation and pain at 8 days and 15 days. Three percent of patients in both difluprednate groups had a clinically significant IOP rise (>or=10 mm Hg and >or=21 mm Hg from baseline, respectively) versus 1% in the placebo group. CONCLUSIONS: Difluprednate given 2 or 4 times a day cleared postoperative inflammation and reduced pain rapidly and effectively. There were no serious ocular adverse events. Fewer adverse events were reported in the difluprednate-treated groups than in the placebo group.