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Topical Cyclosporine and Disease Progression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567983
First Posted: December 5, 2007
Last Update Posted: September 25, 2008
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:
Innovative Medical
  Purpose
The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.

Condition Intervention Phase
Disease Progression Disease Severity Staining Schirmers OSDI Drug: Restasis Drug: Endura Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Topical Cyclosporine and Disease Progression

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Disease Severity [ Time Frame: 1 yr ]

Secondary Outcome Measures:
  • Staining [ Time Frame: 1 yr ]

Estimated Enrollment: 80
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Drug: Restasis
Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
Placebo Comparator: 2. Drug: Endura
Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mild to Moderate dry eye symptoms

Exclusion Criteria:

  • Current use of Restasis
  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): NCT00567983


Locations
United States, Illinois
Lakeside Eye Clinic
Chicago, Illinois, United States, 60641
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: Sanjay Rao Lakeside Eye Clinic
  More Information

Responsible Party: Sanjay Rao, MD, Lakeside Eye Clinic
ClinicalTrials.gov Identifier: NCT00567983     History of Changes
Other Study ID Numbers: 13717A
First Submitted: December 3, 2007
First Posted: December 5, 2007
Last Update Posted: September 25, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Disease Progression
Disease Attributes
Pathologic Processes
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