NCT01488396

CompletedPhase 4

Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Sy...

Mahidol University Source

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Other study identifiers

Sponsor study identifier

336/2549

Study Type

interventional

Actual enrollment (reported)

31

Locations

1 country

Sites

1

Timeline

Study Start

February 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2009

Actual (reported)

Study Completion

July 2009

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 31 participants
Study completion date: July 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2007
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
July 2009
Actual (reported)
Study Completion
July 2009
Actual (reported)
First Submitted
November 8, 2010
Actual (reported)
First Posted
December 8, 2011
Actual (reported)

Last Updated: December 8, 2011
Status Verified: December 2011
Last Update Submitted: December 6, 2011

Conditions

Stevens-Johnson Syndrome

Keywords

CyclosporinStevens-Johnson syndromeDry 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 dropDrug

use twice daily for 6 months

Also known as: cyclosporin A

0.05%cyclosporin eye drop

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Mahidol University
Otherlead

Study Sites (1)

Mahidol university

Bangkok, Thailand

MeSH Terms

Conditions

Stevens-Johnson SyndromeDry Eye Syndromes

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

StomatitisMouth DiseasesStomatognathic DiseasesDrug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesErythema MultiformeErythemaSkin Diseases, VesiculobullousHypersensitivity, Delayed

Study Officials

Pinnita Prabhasawat, MD
Mahidol University
PRINCIPAL INVESTIGATOR

Enrollment

31 participants (actual enrollment reported by the registry).

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 2007

Date type not reported

This date has not been verified as actual or estimated.

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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

Contact the study team to confirm eligibility.

Hypersensitivity

Immune System Diseases

Drug Hypersensitivity

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Lacrimal Apparatus Diseases

Eye Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Primary Completion

July 2009

Actual (reported)

Study Completion

July 2009

Actual (reported)

Last Updated

December 8, 2011

Record last verified: 2011-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01488396
Data provider: ClinicalTrials.gov
Source updated: 2011-12-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:17 UTC

Locations

TH(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

0.05%cyclosporin eye drop

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations