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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01488396
Recruitment Status : Completed
First Posted : December 8, 2011
Last Update Posted : December 8, 2011
Information provided by (Responsible Party):
Pinnita Prabhasawat, Mahidol University

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.

Condition or disease Intervention/treatment Phase
Stevens-Johnson Syndrome Drug: 0.05%cyclosporin eye drop Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
Study Start Date : February 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: 0.05%cyclosporin eye drop Drug: 0.05%cyclosporin eye drop
use twice daily for 6 months
Other Name: cyclosporin A

Primary Outcome Measures :
  1. dry eyes symptoms : dryness, gritty, photophobia, burning and pain [ Time Frame: 0, 2, 4, 6 months ]

Secondary Outcome Measures :
  1. Schirmer I test [ Time Frame: 0, 6 months ]
  2. Fluorescein clearance test (FCT) [ Time Frame: 0, 6 month ]
  3. Corneal staining [ Time Frame: 0, 2, 4, 6 months ]
    Staining with fluorescein and rose bengal

  4. Fluorescein tear break up time [ Time Frame: 0, 2. 4. 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01488396

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Mahidol university
Bangkok, Thailand
Sponsors and Collaborators
Mahidol University
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Principal Investigator: Pinnita Prabhasawat, MD Mahidol University

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Responsible Party: Pinnita Prabhasawat, Associated professor, Mahidol University Identifier: NCT01488396    
Other Study ID Numbers: 336/2549
First Posted: December 8, 2011    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011
Keywords provided by Pinnita Prabhasawat, Mahidol University:
Stevens-Johnson syndrome
Dry eye
Additional relevant MeSH terms:
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Stevens-Johnson Syndrome
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Drug Eruptions
Skin Diseases
Erythema Multiforme
Skin Diseases, Vesiculobullous
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Ophthalmic Solutions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents