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

Primary Purpose

Stevens-Johnson Syndrome

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

0.05%cyclosporin eye drop

About this trial

This is an interventional treatment trial for Stevens-Johnson Syndrome focused on measuring Cyclosporin, Stevens-Johnson syndrome, Dry eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mahidol university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

0.05%cyclosporin eye drop

Arm Description

Outcomes

Primary Outcome Measures

dry eyes symptoms : dryness, gritty, photophobia, burning and pain

Secondary Outcome Measures

Schirmer I test

Fluorescein clearance test (FCT)

Corneal staining

Staining with fluorescein and rose bengal

Fluorescein tear break up time

Full Information

NCT ID

NCT01488396

First Posted

November 8, 2010

Last Updated

December 6, 2011

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT01488396

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stevens-Johnson Syndrome

Keywords

Cyclosporin, Stevens-Johnson syndrome, Dry eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.05%cyclosporin eye drop

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

0.05%cyclosporin eye drop

Other Intervention Name(s)

cyclosporin A

Intervention Description

use twice daily for 6 months

Primary Outcome Measure Information:

Title

dry eyes symptoms : dryness, gritty, photophobia, burning and pain

Time Frame

0, 2, 4, 6 months

Secondary Outcome Measure Information:

Title

Schirmer I test

Time Frame

0, 6 months

Title

Fluorescein clearance test (FCT)

Time Frame

0, 6 month

Title

Corneal staining

Description

Staining with fluorescein and rose bengal

Time Frame

0, 2, 4, 6 months

Title

Fluorescein tear break up time

Time Frame

0, 2. 4. 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 has dry eye symptom everyday for more than 3 months has foreign body sensation frequently use tear substitutes more than 3 times per day Tear test shaw abnormalities at least 1 of 2 of following: Schirmer test without anesthesia is not more than 5 millimeters in 5 minutes 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pinnita Prabhasawat, MD

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mahidol university

City

Bangkok

Country

Thailand

12. IPD Sharing Statement

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

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