Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.
OBJECTIVE
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.


METHODS
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.
Korenfeld
Michael S
MS
Comprehensive Eye Care Ltd., 901 East 3rd Street, Washington, Missouri 63090, USA. michaelkorenfeld@hotmail.com
Silverstein
Steven M
SM
Cooke
David L
DL
Vogel
Roger
R
Crockett
Robert S
RS
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000867:Anterior Chamber / Q000187:drug effects / Q000473:pathology; D002452:Cell Count; D004311:Double-Blind Method; D004655:Emulsions; D005260:Female; D005477:Fluprednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007249:Inflammation / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects; D013508:Ophthalmologic Surgical Procedures; D010146:Pain / Q000188:drug therapy* / Q000503:physiopathology; D011183:Postoperative Complications; D014606:Uveitis, Anterior / Q000188:drug therapy* / Q000503:physiopathology
D004655:Emulsions; D005938:Glucocorticoids; D009883:Ophthalmic Solutions; D005477:Fluprednisolone; C015808:difluprednate