Clinical Trial: Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
Brief Summary: The purpose of this study is to evaluate the efficacy of 0.05% cyclosporin ophthalmic emulsion (Restasis) in patients with Stevens-Johnson syndrome that have dry eyes by subjective symptoms and signs.
Detailed Summary: Stevens-Johnson syndrome patients in chronic stage who have dry eys symptoms and signs will be treated with 0.05%cyclosporin ophthalmic emulsion(Restasis)twice a day for 6 months, compare results at 0,2,4,6 months include dry eye symptoms, corneal staining (Fluorescein, Rose Bengal), Schirmer I,FCT and impression cytology
Sponsor: Mahidol University
Current Primary Outcome: dry eyes symptoms : dryness, gritty, photophobia, burning and pain [ Time Frame: 0, 2, 4, 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Schirmer I test [ Time Frame: 0, 6 months ]
- Fluorescein clearance test (FCT) [ Time Frame: 0, 6 month ]
- Corneal staining [ Time Frame: 0, 2, 4, 6 months ]Staining with fluorescein and rose bengal
- Fluorescein tear break up time [ Time Frame: 0, 2. 4. 6 months ]
Original Secondary Outcome: Same as current
Information By: Mahidol University
Dates:
Date Received: November 8, 2010
Date Started: February 2007
Date Completion:
Last Updated: December 6, 2011
Last Verified: December 2011
