Document Detail


Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis.
MedLine Citation:
PMID:  20809807     Owner:  NLM     Status:  In-Process    
Abstract/OtherAbstract:
PURPOSE: The aim of this study was to evaluate the efficacy and safety of difluprednate ophthalmic solution 0.05% (Durezol; Alcon Laboratories, Fort Worth, TX) compared with prednisolone acetate ophthalmic suspension 1% (Pred Forte; Allergan, Inc., Irvine, CA) for endogenous anterior uveitis.
METHODS: In this phase 3, multicenter, randomized, noninferiority trial, 90 patients with endogenous anterior uveitis [>10 anterior chamber (AC) cells and an AC flare score of ≥2 in at least 1 eye] received either difluprednate 4x /day (QID) (n=50) or prednisolone 8x/day (n=40) for 14 days, followed by a 2-week tapering regimen. The main outcome measure was change from baseline in AC cell grade on day 14.
RESULTS: At day 14, mean AC cell grade improvement for difluprednate-treated patients was similar to prednisolone-treated patients (2.1 vs. 1.9, respectively), proving noninferiority. At day 14, 68.8% of difluprednate patients had AC cell clearing (grade 0:≥ 1cell) compared with 61.5% of prednisolone patients. In the prednisolone-treated group, 12.5% of patients were withdrawn because of investigator-determined lack of efficacy; no difluprednate-treated patients were withdrawn for this reason (P=0.01). Clinically significant intraocular pressure elevation occurred in 3 difluprednate-treated patients (6.0%) and 2 prednisolone-treated patients (5.0%).
CONCLUSIONS: Difluprednate administered QID is at least as effective as prednisolone administered 8x/day in resolving the inflammation and pain associated with endogenous anterior uveitis. Difluprednate provides effective treatment for anterior uveitis and requires less frequent dosing than prednisolone acetate. Clinical trial registration: Trial NCT00501579 was registered at the National Institutes of Health Registry in July 2007 ( http://clinicaltrials.gov/ct2/show/NCT00501579?term=sirion&rank=4 ).
Authors:
C Stephen Foster; Robert Davanzo; Thomas E Flynn; Kimberly McLeod; Roger Vogel; R Steve Crockett
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics     Volume:  26     ISSN:  1557-7732     ISO Abbreviation:  J Ocul Pharmacol Ther     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-10-07     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9511091     Medline TA:  J Ocul Pharmacol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  475-83     Citation Subset:  IM    
Affiliation:
Ocular Immunology and Uveitis Foundation, Harvard Medical School, Massachusetts Eye Research and Surgery Institution , Cambridge, MA 02142, USA. sfoster@mersi.us
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00501579
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