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

NCT01488396 | Completed Phase 4

• 1 other identifier: 336/2549
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Stevens-Johnson Syndrome

Keywords

Cyclosporin; Stevens-Johnson syndrome; Dry eye

Outcome Measures

Primary Outcomes (1)

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

  0, 2, 4, 6 months

Secondary Outcomes (4)

• Schirmer I test

  0, 6 months

• Fluorescein clearance test (FCT)

  0, 6 month

• Corneal staining

  0, 2, 4, 6 months

• Fluorescein tear break up time

  0, 2. 4. 6 months

Study Arms (1)

0.05%cyclosporin eye drop

EXPERIMENTAL

Drug: 0.05%cyclosporin eye drop

Interventions

0.05%cyclosporin eye drop DRUG

use twice daily for 6 months

Also known as: cyclosporin A

0.05%cyclosporin eye drop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Mahidol university

Bangkok, Thailand

Location

MeSH Terms

Conditions

Stevens-Johnson Syndrome; Dry Eye Syndromes

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Pinnita Prabhasawat, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: December 8, 2011
• Study Start: February 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 8, 2011

Record last verified: 2011-12

Locations

TH (1)