Study of Difluprednate in the Treatment of Uveitis

Sponsor
Sirion Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00501579
Collaborator
(none)
1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Diagnosis of endogenous anterior uveitis in at least 1 eye
    Exclusion Criteria:
    • Presence of intermediate uveitis, posterior uveitis or panuveitis

    • Corneal abrasion

    • Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease

    • Allergy to similar drugs, such as other corticosteroids

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 John-Kenyon American Eye Institute New Albany Indiana United States 47150

    Sponsors and Collaborators

    • Sirion Therapeutics, Inc.

    Investigators

    • Study Chair: Roger Vogel, MD, Sirion Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00501579
    Other Study ID Numbers:
    • ST-601A-001
    First Posted:
    Jul 16, 2007
    Last Update Posted:
    Aug 29, 2008
    Last Verified:
    Aug 1, 2008

    Study Results

    No Results Posted as of Aug 29, 2008