Status:
COMPLETED
Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
Lead Sponsor:
Mahidol University
Conditions:
Stevens-Johnson Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Description
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...
Eligibility Criteria
Inclusion
- Males or females, of legal age of consent
- Patient with Stevens-Johnson syndrome in chronic stage or has symptoms more than 3 months and has dry eye symptoms
- Dry eye symptoms are defined as
- has dry eye symptom everyday for more than 3 months
- has foreign body sensation frequently
- use tear substitutes more than 3 times per day
- Tear test shaw abnormalities at least 1 of 2 of following:
- Schirmer test without anesthesia is not more than 5 millimeters in 5 minutes
- Fluorescein clearance test at first 10 minutes is not more than 3 millimeters and has at least 1 of 3 of the following:
- 1.Rose Bengal score is not less than 4 2.2.Fluorescein stain at cornea 2.3.Impression cytology is consistent to dry eye
- Patent punctum
Exclusion
- Age \< 18 years old
- Patients with Steven Johnson syndrome without dry eye
- Patients used oral cyclosporine or anticholinergic drug within past 2 months
- Patients with HIV or immunocompromise status
- Patients with active ocular infections and patients with a history of herpes keratitis
- Patients with known or suspected hypersensitivity to any of the ingredients in the formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342)
- Female patients are pregnant or nursing
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01488396
Start Date
February 1 2007
End Date
July 1 2009
Last Update
December 8 2011
Active Locations (1)
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1
Mahidol university
Bangkok, Thailand