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Trial record 6 of 285 for:    603

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502073
First Posted: July 17, 2007
Last Update Posted: July 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sirion Therapeutics, Inc.
  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 3

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

Resource links provided by NLM:


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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00502073     History of Changes
Other Study ID Numbers: ST-603-005
First Submitted: July 13, 2007
First Posted: July 17, 2007
Last Update Posted: July 1, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporins
Cyclosporine
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