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

AbstractOBJECTIVE:
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).
CONCLUSIONS:
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.
AuthorsStephen Smith, Douglas Lorenz, James Peace, Kimberly McLeod, R S Crockett, Roger Vogel
JournalClinical ophthalmology (Auckland, N.Z.) (Clin Ophthalmol) Vol. 4 Pg. 983-91 ( 2010) ISSN: 1177-5483 [Electronic] New Zealand
PMID20856594 (Publication Type: Journal Article)

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