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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.05%cyclosporin eye drop | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.05%cyclosporin eye drop | Drug | use twice daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| dry eyes symptoms : dryness, gritty, photophobia, burning and pain | 0, 2, 4, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Schirmer I test | 0, 6 months | |
| Fluorescein clearance test (FCT) | 0, 6 month | |
| Corneal staining |
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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
Tear test shaw abnormalities at least 1 of 2 of 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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pinnita Prabhasawat, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahidol university | Bangkok | Thailand |
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| ID | Term |
|---|---|
| D013262 | Stevens-Johnson Syndrome |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003875 | Drug Eruptions |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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Staining with fluorescein and rose bengal
| 0, 2, 4, 6 months |
| Fluorescein tear break up time | 0, 2. 4. 6 months |
| D003872 |
| Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004892 | Erythema Multiforme |
| D004890 | Erythema |
| D012872 | Skin Diseases, Vesiculobullous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |