Back to Journals » Clinical Ophthalmology » Volume 4

Difluprednate ophthalmic emulsion 0.05% (Durezol®) administered two times daily for managing ocular inflammation and pain following cataract surgery

Authors Smith S, Lorenz D, Peace J, McLeod K, Crockett R, Vogel R

Published 30 August 2010 Volume 2010:4 Pages 983—991


Review by Single anonymous peer review

Peer reviewer comments 4

Stephen Smith1, Douglas Lorenz2, James Peace3, Kimberly McLeod4, RS Crockett5, Roger Vogel4, and the Difluprednate ST601-004 Study Group

1Eye Associates of Fort Myers, Fort Myers, Florida, USA; 2Nevada Eye and Ear, Henderson, Nevada, USA; 3United Medical Research, Inglewood, California, USA; 4Sirion Therapeutics, Inc., Tampa, Florida, USA; 5DATA, Inc., Bayou La Batre, Alabama, USA. Clinical trial registration number: NCT00616993

Objective: To evaluate the efficacy and safety of twice-daily difluprednate ophthalmic ­emulsion 0.05% (Durezol®) versus placebo administered before surgery for managing inflammation and pain following cataract extraction.

Methods: Eligible subjects (N = 121) were randomized 2:1 to topical treatment with 1 drop difluprednate or placebo administered twice daily for 16 days, followed by a 14-day ­tapering period. Dosing was initiated 24 hours before unilateral ocular surgery. Clinical signs of ­inflammation (anterior chamber [AC] cell and flare grade, bulbar conjunctival injection, ciliary injection, corneal edema, and chemosis), ocular pain/discomfort, intraocular pressure (IOP), and adverse events were assessed.

Results: Clearing of inflammation on day 14 (primary endpoint), defined as an AC cell grade of 0 (≤5 cells) and a flare grade of 0 (complete absence), was achieved in a significantly greater percentage of subjects treated with difluprednate, compared with placebo (74.7% ­vs 42.5%; P = 0.0006). A significantly greater percentage of difluprednate-treated subjects were free of ocular pain/discomfort on day 14 than placebo-treated subjects (64.6% vs 30.0%; P = 0.0004). Three subjects (3.7%) in the difluprednate group had a clinically significant IOP rise (defined as ≥21 mmHg and a change from baseline ≥10 mmHg at same visit).

Difluprednate, administered 2 times daily starting 24 hours before cataract ­surgery, was highly effective for managing ocular inflammation and relieving pain and discomfort postoperatively. Difluprednate was well tolerated and provides a convenient twice-daily option for managing postoperative ocular inflammation.

difluprednate, safety, efficacy, twice daily, postoperative ocular inflammation, corticosteroids

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]