Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

This study has been completed.

First Received on November 30, 2007. Last Updated on July 29, 2010 History of Changes

Sponsor:	Innovative Medical
Information provided by:	Innovative Medical
ClinicalTrials.gov Identifier:	NCT00567177

Purpose

We propose to investigate the response to Restasis, over a prolonged period of time in heavy computer users with dry eye disease.

Condition	Intervention	Phase
Treatment of Dry Eye Disease	Drug: Restasis, Refresh Plus	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Further study details as provided by Innovative Medical:

Primary Outcome Measures:

Dry Eye disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	November 2007
Study Completion Date:	April 2008

Arms	Assigned Interventions
Active Comparator: 1	Drug: Restasis, Refresh Plus Restasis 0.4ml- (in the eye) Instill one drop twice daily in morning and evening Refresh Plus 0.4ml- (in the eye) Instill one drop twice daily in morning and evening
Placebo Comparator: 2	Drug: Restasis, Refresh Plus Restasis 0.4ml- (in the eye) Instill one drop twice daily in morning and evening Refresh Plus 0.4ml- (in the eye) Instill one drop twice daily in morning and evening

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Using computers more than three hours per day
Having dry eye symptoms based on results on the OSDI Scores of 15 or greater on the OSDI will be considered to have the disorder
An abnormal confocal image of 5 or greater.

Exclusion Criteria:

All corneal disorders except for tear disorders.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567177

Locations

United States, Texas
Hermann Eye Center
6400 Fannin Ste 1800, Texas, United States, 77030

Sponsors and Collaborators

Innovative Medical

Investigators

Principal Investigator:

Richard Yee, MD

Hermann Eye Center

More Information

No publications provided

Responsible Party:	Richard Yee, MD, Hermann Eye Center
ClinicalTrials.gov Identifier:	NCT00567177 History of Changes
Other Study ID Numbers:	HSC-MS-07-0421
Study First Received:	November 30, 2007
Last Updated:	July 29, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
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 12, 2012