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Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT00567177
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : July 30, 2010
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Treatment of Dry Eye Disease Drug: Restasis, Refresh Plus Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease
Study Start Date : November 2007
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Dry Eye disease [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. efficacy [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Richard Yee, MD, Hermann Eye Center
ClinicalTrials.gov Identifier: NCT00567177     History of Changes
Other Study ID Numbers: HSC-MS-07-0421
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: July 30, 2010
Last Verified: July 2010

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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors