Topical Cyclosporine and Disease Progression

This study has been completed.

First Received on December 3, 2007. Last Updated on September 23, 2008 History of Changes

Sponsor:	Innovative Medical
Information provided by:	Innovative Medical
ClinicalTrials.gov Identifier:	NCT00567983

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 IV

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:

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

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

Eligibility

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

Criteria

Inclusion Criteria:

Mild to Moderate dry eye symptoms

Exclusion Criteria:

Current use of Restasis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Sanjay Rao, MD, Lakeside Eye Clinic
ClinicalTrials.gov 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
Cyclosporins
Cyclosporine
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

ClinicalTrials.gov processed this record on February 09, 2012