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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Stevens-Johnson Syndrome

Treatments: Drug: 0.05%cyclosporin eye drop

Study type: Interventional

Funder types: Other

Identifiers

NCT01488396

336/2549

Details and patient eligibility

About

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.

Full 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

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

0.05%cyclosporin eye drop

Experimental group

Treatment:

Drug: 0.05%cyclosporin eye drop