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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01488396
• Date of registration: 08/11/2010
• Prospective Registration: No
• Primary sponsor: Mahidol University
• Public title: Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
• Scientific title: Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
• Date of first enrolment: February 2007
• Target sample size: 31
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01488396
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Thailand

Contacts

• Name: Pinnita Prabhasawat, MD
• Affiliation: Mahidol University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Stevens-Johnson Syndrome

Intervention(s)

Drug: 0.05%cyclosporin eye drop

Primary Outcome(s)

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

Secondary Outcome(s)

Schirmer I test [Time Frame: 0, 6 months]

Corneal staining [Time Frame: 0, 2, 4, 6 months]

Fluorescein tear break up time [Time Frame: 0, 2. 4. 6 months]

Fluorescein clearance test (FCT) [Time Frame: 0, 6 month]

Secondary ID(s)

336/2549

Source(s) of Monetary Support

Please refer to primary and secondary sponsors