Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers

This study has been completed.

Sponsored by:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00335114

Purpose

Cyclosporine Ophthalmic Emulsion is currently used in the treatment of dry eye syndrome. Contact lens wearers frequently suffer from dry eye syndrome. The purpose of this study is to evaluate cyclosporine ophthalmic emulsion verses re-wetting drops in the relief of dry eye symptoms in contact lens wearers

Condition	Intervention
Contact Lens Wearers With Dry Eye Syndrome	Drug: cyclosporine ophthalmic emulsion

MedlinePlus related topics: Eye Wear

Drug Information available for: Cyclosporin Cyclosporine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Ocular exams and questionnaires at baseline and at 3 months will determine
the effect of cyclosporine on dry eye syndrome.

Secondary Outcome Measures:

Increased contact lens wearing time due to a decrease in severity
of dry eye symptoms

Estimated Enrollment:	40
Study Start Date:	November 2005
Estimated Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

contact lens wearer
clinical diagnosis of dry eye syndrome

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335114

Locations

United States, Alabama
UAB Ophthalmology Services Foundation
Birmingham, Alabama, United States, 35233

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator:

Carol E Rosenstiel, OD

University of Alabama at Birmingham

More Information

Study ID Numbers:	F051025017
Study First Received:	June 7, 2006
Last Updated:	June 8, 2006
ClinicalTrials.gov Identifier:	NCT00335114
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

cyclosporine, dry eye syndrome, contact lens

Study placed in the following topic categories:

Cyclosporine
Clotrimazole
Miconazole
Eye Diseases

Tioconazole
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Disease
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents

Pharmacologic Actions
Pathologic Processes
Syndrome
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009