Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-005)

This study has been completed.

First Received: July 13, 2007 Last Updated: February 29, 2008 History of Changes

Sponsor:	Sirion Therapeutics, Inc.
Information provided by:	Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00502073

Purpose

The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome.

Condition	Intervention	Phase
Dry Eye Syndromes	Drug: cyclosporine	Phase III

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment

Resource links provided by NLM:

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Diagnosis of moderate to severe dry eye syndrome with or without Sjogren's syndrome or other autoimmune disease

Exclusion Criteria:

Intraocular or refractive surgery in the study eye within 3 months prior to study start
Unwilling to discontinue use of contact lenses during the run-in and duration of the study
Pregnancy or lactation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502073

Locations

United States, Maine
Eye Center Northeast
Bangor, Maine, United States, 04401

Sponsors and Collaborators

Sirion Therapeutics, Inc.

Investigators

Study Chair:

Roger Vogel, MD

Sirion Therapeutics

More Information

No publications provided

Study ID Numbers:	ST-603-005
Study First Received:	July 13, 2007
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00502073 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Disease
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Eye Diseases
Physiological Effects of Drugs
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Enzyme Inhibitors

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

ClinicalTrials.gov processed this record on November 30, 2009