Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain
Received 11 July 2008; received in revised form 4 September 2008; accepted 5 September 2008.
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.
From private practices, Washington, Missouri (Korenfeld), Kansas City, Missouri (Silverstein), St. Joseph, Michigan (Cooke); Sirion Therapeutics (Vogel), Tampa, Florida; and DATA, Inc. (Crockett), Mobile, Alabama, USA
Corresponding author: Michael Korenfeld, MD, Comprehensive Eye Care, Ltd., 901 East 3rd Street, Washington, Missouri 63090, USA.
Clinical trial study numbers NCT00430092 and NCT00429923.
Drs. Korenfeld, Silverstein, Cooke, and Crockett are consultants to Sirion Therapeutics. Dr. Vogel has a financial interest.
Supported by Sirion Therapeutics, Tampa, Florida, USA.
Presented at the ASCRS Symposium on Cataract, IOL and Refractive Surgery, Chicago, Illinois, USA, April 2008.
ABSTRACT