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