Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

This study is currently recruiting participants.

Verified by Innovative Medical, September 2008

First Received: November 30, 2007 Last Updated: September 23, 2008 History of Changes

Sponsored by:	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:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
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
Estimated Study Completion Date:	April 2008

Arms	Assigned Interventions
1: Active Comparator	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
2: Placebo Comparator	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

Contacts

Contact: Melissa Earl	951-786-0403	m.earl@imedsonline.com
Contact: Jessica James	951-786-0403	jessie_imeds@sbcglobal.net

Locations

United States, Texas
Hermann Eye Center	Recruiting
6400 Fannin Ste 1800, Texas, United States, 77030
Contact: Richard Yee, MD 713-559-1777 Richard.W.Yee@uth.tmc.edu

Sponsors and Collaborators

Innovative Medical

Investigators

Principal Investigator:

Richard Yee, MD

Hermann Eye Center

More Information

No publications provided

Responsible Party:	Hermann Eye Center ( Richard Yee, MD )
Study ID Numbers:	HSC-MS-07-0421
Study First Received:	November 30, 2007
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00567177 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Cyclosporine
Immunologic Factors
Antifungal Agents
Eye Diseases

Antirheumatic Agents
Immunosuppressive Agents
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Eye Diseases
Physiological Effects of Drugs
Enzyme Inhibitors

Cyclosporins
Immunosuppressive Agents
Pharmacologic Actions
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 06, 2009