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

Phase 4

Completed

• Conditions: Stevens-Johnson Syndrome
• Interventions: Drug: 0.05%cyclosporin eye drop

• Registration Number: NCT01488396
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-02
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2010-11-08
• Status Verified: 2011-12
• Study First Submitted QC: 2011-12-06
• Last Update Submitted: 2011-12-06
• Study First Posted: 2011-12-08
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
0.05%cyclosporin eye drop	0.05%cyclosporin eye drop	-

Primary Outcome Measures

Name	Time	Method
dry eyes symptoms : dryness, gritty, photophobia, burning and pain	0, 2, 4, 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mahidol university; 🇹🇭 Bangkok, Thailand