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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Treatments: Cyclosporine; Cyclosporins; Ophthalmic Solutions; Tetrahydrozoline

Criteria

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

1. has dry eye symptom everyday for more than 3 months

2. has foreign body sensation frequently

3. use tear substitutes more than 3 times per day

• Tear test shaw abnormalities at least 1 of 2 of following:

1. Schirmer test without anesthesia is not more than 5 millimeters in 5 minutes

2. 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