Clinical Trial: Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Inluding Iritis, Cyclitis, Iridocyclitis, and
Brief Summary: The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.
Detailed Summary:
The primary objective was to investigate the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with endogenous anterior uveitis and to determine its clinical usefulness for treatment of this disease in the early phase of development, in comparison with Rinderon® solution (containing 0.1% betamethasone sodium phosphate) that has widely been used for treatment of postoperative inflammation, uveitis, etc. as a steroid ophthalmic solution.
The secondary objective was to establish the evaluation system for a dose-finding study.
Sponsor: Sirion Therapeutics, Inc.
Current Primary Outcome:
- The anterior chamber cell score was compared between baseline and after completion of the
- study treatment (14 +/- 2 days). The efficacy was evaluated with a 4-point scale based on the
- reduction of anterior chamber cell.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The overall efficacy was evaluated with a 4-point-scale based on the change in the flare value
- (baseline/after completion of the study treatment ratio), as measured with a laser flare cell
- meter, and those in anterior chamber flare as measured with a slitlamp microscope and clinical
- signs and symptoms after completion of the study treatment (142 days) from baseline.
Original Secondary Outcome: Same as current
Information By: Sirion Therapeutics, Inc.
Dates:
Date Received: November 29, 2006
Date Started: March 2000
Date Completion: April 2001
Last Updated: November 29, 2006
Last Verified: November 2006
