Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye

Study Overview
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Brief Summary
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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
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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

Official Title
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Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye

Conditions
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Stevens-Johnson Syndrome

Intervention / Treatment
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* Drug: 0.05%cyclosporin eye drop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 2.1.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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.05%cyclosporin eye drop<br> | Drug: 0.05%cyclosporin eye drop<br>* use twice daily for 6 months<br>* Other names: cyclosporin A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dry eyes symptoms : dryness, gritty, photophobia, burning and pain |  | 0, 2, 4, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schirmer I test |  | 0, 6 months | 
| Fluorescein clearance test (FCT) |  | 0, 6 month | 
| Corneal staining | Staining with fluorescein and rose bengal | 0, 2, 4, 6 months | 
| Fluorescein tear break up time |  | 0, 2. 4. 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclosporin, Stevens-Johnson syndrome, Dry eye