Topical Cyclosporine and Disease Progression

This study has been completed.
Information provided by:
Innovative Medical Identifier:
First received: December 3, 2007
Last updated: September 23, 2008
Last verified: September 2008

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

Condition Intervention Phase
Disease Progression
Disease Severity
Drug: Restasis
Drug: Endura
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Staining [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Mild to Moderate dry eye symptoms

Exclusion Criteria:

  • Current use of Restasis
  Contacts and Locations
Please refer to this study by its identifier: NCT00567983

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

No publications provided

Responsible Party: Sanjay Rao, MD, Lakeside Eye Clinic Identifier: NCT00567983     History of Changes
Other Study ID Numbers: 13717A
Study First Received: December 3, 2007
Last Updated: September 23, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Disease Progression
Disease Attributes
Pathologic Processes
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 processed this record on April 17, 2014