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

This study has been completed.
Information provided by:
Sirion Therapeutics, Inc. Identifier:
First received: October 22, 2007
Last updated: June 29, 2011
Last verified: June 2011
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind

Resource links provided by NLM:

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00548301

United States, Maine
Eye Center Northeast
Bangor, Maine, United States, 04401
Sponsors and Collaborators
Sirion Therapeutics, Inc.
Study Chair: Roger Vogel, MD Sirion Therapeutics
  More Information 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:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors processed this record on October 21, 2016