M. Korenfeld, S. Silverstein, D. Cooke
Jan 1, 2009
Citations
4
Influential Citations
99
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Quality indicators
Journal
Journal of Cataract and Refractive Surgery
Abstract
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, ≤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 (≥10 mm Hg and ≥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.