Clinical Trial: Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe Anterior Uveitis (Including Panuveitis).
Brief Summary: The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis.
Detailed Summary: The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with severe endogenous anterior uveitis with an open-labeled, no-controlled and no-randomized design.
Sponsor: Sirion Therapeutics, Inc.
Current Primary Outcome: The anterior chamber cell score was compared between baseline and Day 14.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The anterior chamber cell score was compared between baseline and Days 3 and 7.
- The total symptom score (sum of eye pain, photophobia, blurred
- vision, foreign body sensation and lacrimation scores) and total
- sign score (sum of anterior chamber cell, anterior chamber flare,
- ciliary hyperemia, keratic precipitate and synechia of iris and
- posterior scores) were compared between baseline and Days 3, 7
- and 14.
Original Secondary Outcome: Same as current
Information By: Sirion Therapeutics, Inc.
Dates:
Date Received: November 29, 2006
Date Started: August 2002
Date Completion: June 2003
Last Updated: November 29, 2006
Last Verified: November 2006
