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

December 6, 2011 updated by: Pinnita Prabhasawat, Mahidol University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.05%cyclosporin eye drop
Drug: 0.05%cyclosporin eye drop
use twice daily for 6 months
Other Names:
  • cyclosporin A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
dry eyes symptoms : dryness, gritty, photophobia, burning and pain
Time Frame: 0, 2, 4, 6 months
0, 2, 4, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schirmer I test
Time Frame: 0, 6 months
0, 6 months
Fluorescein clearance test (FCT)
Time Frame: 0, 6 month
0, 6 month
Corneal staining
Time Frame: 0, 2, 4, 6 months
Staining with fluorescein and rose bengal
0, 2, 4, 6 months
Fluorescein tear break up time
Time Frame: 0, 2. 4. 6 months
0, 2. 4. 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Pinnita Prabhasawat, MD, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Estimate)

December 8, 2011

Last Update Submitted That Met QC Criteria

December 6, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 336/2549

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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