Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
NCT ID: NCT01488396
Last Updated: 2011-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
31 participants
INTERVENTIONAL
2007-02-28
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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0.05%cyclosporin eye drop
0.05%cyclosporin eye drop
use twice daily for 6 months
Interventions
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0.05%cyclosporin eye drop
use twice daily for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Pinnita Prabhasawat
Associated professor
Principal Investigators
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Pinnita Prabhasawat, MD
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Mahidol university
Bangkok, , Thailand
Countries
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Other Identifiers
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336/2549
Identifier Type: -
Identifier Source: org_study_id