Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.

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, <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.

• Authors: Michael S Korenfeld, Steven M Silverstein, David L Cooke, Roger Vogel, Robert S Crockett, Difluprednate Ophthalmic Emulsion 0.05% (Durezol) Study Group
• Journal: Journal of cataract and refractive surgery (J Cataract Refract Surg) Vol. 35 Issue 1 Pg. 26-34 (Jan 2009) ISSN: 0886-3350 [Print] United States
• PMID: 19101421 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Emulsions
• Glucocorticoids
• Ophthalmic Solutions
• Fluprednisolone
• difluprednate

Topics

• Adult
• Aged
• Aged, 80 and over
• Anterior Chamber (drug effects, pathology)
• Cell Count
• Double-Blind Method
• Emulsions
• Female
• Fluprednisolone (administration & dosage, adverse effects, analogs & derivatives)
• Glucocorticoids (administration & dosage, adverse effects)
• Humans
• Inflammation (drug therapy)
• Male
• Middle Aged
• Ophthalmic Solutions (administration & dosage, adverse effects)
• Ophthalmologic Surgical Procedures
• Pain (drug therapy, physiopathology)
• Postoperative Complications
• Uveitis, Anterior (drug therapy, physiopathology)