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

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

This study has been completed.

Sponsored by:	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

ChemIDplus related topics:

Cyclosporine Cyclosporin

U.S. FDA Resources

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

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

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

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 October 10, 2008