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Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT00567177
First received: November 30, 2007
Last updated: July 29, 2010
Last verified: July 2010
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Cyclosporine
Cyclosporins
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014