Stevens-Johnson Syndrome
Conditions
Keywords
Cyclosporin, Stevens-Johnson syndrome, 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 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 0,2,4,6 months include dry eye symptoms, corneal staining (Fluorescein, Rose Bengal), Schirmer I,FCT and impression cytology
Interventions
DRUG0.05%cyclosporin eye drop
use twice daily for 6 months
Sponsors
Mahidol University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dry eyes symptoms : dryness, gritty, photophobia, burning and pain | 0, 2, 4, 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Schirmer I test | 0, 6 months | — |
| Fluorescein clearance test (FCT) | 0, 6 month | — |
| Corneal staining | 0, 2, 4, 6 months | Staining with fluorescein and rose bengal |
| Fluorescein tear break up time | 0, 2. 4. 6 months | — |
Countries
Thailand
Outcome results
None listed