Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-007)

This study has been completed.

First Received on October 22, 2007. Last Updated on June 29, 2011 History of Changes

Sponsor:	Sirion Therapeutics, Inc.
Information provided by:	Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00548301

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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind

Resource links provided by NLM:

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Further study details as provided by Sirion Therapeutics, Inc.:

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: NCT00548301

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

ClinicalTrials.gov Identifier:	NCT00548301 History of Changes
Other Study ID Numbers:	ST-603-007
Study First Received:	October 22, 2007
Last Updated:	June 29, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Cyclosporins
Cyclosporine

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012