Brief Title
Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
Official Title
Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic 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
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
dry eyes symptoms : dryness, gritty, photophobia, burning and pain
Secondary Outcome
Schirmer I test
Condition
Stevens-Johnson Syndrome
Intervention
0.05%cyclosporin eye drop
Study Arms / Comparison Groups
0.05%cyclosporin eye drop
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
31
Start Date
February 2007
Completion Date
July 2009
Primary Completion Date
July 2009
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pinnita Prabhasawat, MD, ,
Location Countries
Thailand
Location Countries
Thailand
Administrative Informations
NCT ID
NCT01488396
Organization ID
336/2549
Responsible Party
Principal Investigator
Study Sponsor
Mahidol University
Study Sponsor
Pinnita Prabhasawat, MD, Principal Investigator, Mahidol University
Verification Date
December 2011