Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pinnita Prabhasawat, Mahidol University
ClinicalTrials.gov Identifier:
NCT01488396
First received: November 8, 2010
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Stevens-Johnson Syndrome
 Drug: 0.05%cyclosporin eye drop
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • dry eyes symptoms : dryness, gritty, photophobia, burning and pain [ Time Frame: 0, 2, 4, 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Schirmer I test [ Time Frame: 0, 6 months ] [ Designated as safety issue: Yes ]
  • Fluorescein clearance test (FCT) [ Time Frame: 0, 6 month ] [ Designated as safety issue: Yes ]
  • Corneal staining [ Time Frame: 0, 2, 4, 6 months ] [ Designated as safety issue: Yes ]
    Staining with fluorescein and rose bengal

  • Fluorescein tear break up time [ Time Frame: 0, 2. 4. 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: February 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.05%cyclosporin eye drop Drug: 0.05%cyclosporin eye drop
use twice daily for 6 months
Other Name: cyclosporin A

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488396

Locations
Thailand
Mahidol university
Bangkok, Thailand
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Pinnita Prabhasawat, MD Mahidol University
  More Information

No publications provided

Responsible Party: Pinnita Prabhasawat, Associated professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01488396     History of Changes
Other Study ID Numbers: 336/2549
Study First Received: November 8, 2010
Last Updated: December 6, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Cyclosporin
Stevens-Johnson syndrome
Dry eye

Additional relevant MeSH terms:
Stevens-Johnson Syndrome
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Erythema Multiforme
Erythema
Skin Diseases
Skin Diseases, Vesiculobullous
Tetrahydrozoline
Cyclosporins
Cyclosporine
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013