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

Stevens-Johnson Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488396
• Other study ID #: 336/2549
• Status: Completed
• Phase: Phase 4
• First received: November 8, 2010
• Last updated: December 6, 2011
• Start date: February 2007
• Est. completion date: July 2009

Study information

• Verified date: December 2011
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stevens-Johnson Syndrome
• Syndrome

Intervention

Drug:
• 0.05%cyclosporin eye drop
use twice daily for 6 months

Locations

Country	Name	City	State
Thailand	Mahidol university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dry eyes symptoms : dryness, gritty, photophobia, burning and pain		0, 2, 4, 6 months	Yes
Secondary	Schirmer I test		0, 6 months	Yes
Secondary	Fluorescein clearance test (FCT)		0, 6 month	Yes
Secondary	Corneal staining	Staining with fluorescein and rose bengal	0, 2, 4, 6 months	Yes
Secondary	Fluorescein tear break up time		0, 2. 4. 6 months	Yes