Clinical Trial: Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 3 Confirmatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Including Panuveitis).
Brief Summary: The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.
Detailed Summary: The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion (DFBA) in patients with endogenous anterior uveitis, in comparison with 0.1% betamethasone sodium phosphate ophthalmic solution (BP).
Sponsor: Sirion Therapeutics, Inc.
Current Primary Outcome:
- The difference from the baseline in anterior chamber cell score on Day 14
- was compared between the two groups.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The differences from the baseline in anterior chamber cell score on Days 3 and 7
- were compared between the two groups.
- The numbers of patients with an anterior chamber cell score of 0 on Days 7 and
- 14 were compared between the two groups.
- The differences from the baseline in total sign and symptom scores on Days 3, 7
- and 14 were compared between the two groups.
- The numbers of patients with an anterior chamber cell score of 1 or less on Days
- 3, 7 and 14 were compared between the two groups.
Original Secondary Outcome: Same as current
Information By: Sirion Therapeutics, Inc.
Dates:
Date Received: November 29, 2006
Date Started: August 2002
Date Completion: November 2003
Last Updated: November 29, 2006
Last Verified: November 2006