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Topical Cyclosporine and Disease Progression

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ClinicalTrials.gov Identifier: NCT00567983
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : September 25, 2008
Sponsor:
Information provided by:
Innovative Medical

Brief Summary:
The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.

Condition or disease Intervention/treatment Phase
Disease Progression Disease Severity Staining Schirmers OSDI Drug: Restasis Drug: Endura Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Topical Cyclosporine and Disease Progression
Study Start Date : December 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


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

Inclusion Criteria:

  • Mild to Moderate dry eye symptoms

Exclusion Criteria:

  • Current use of Restasis

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

Responsible Party: Sanjay Rao, MD, Lakeside Eye Clinic
ClinicalTrials.gov Identifier: NCT00567983     History of Changes
Other Study ID Numbers: 13717A
First Posted: December 5, 2007    Key Record Dates
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