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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

November 30, 2007
July 29, 2010
November 2007
Not Provided
Dry Eye disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00567177 on ClinicalTrials.gov Archive Site
efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease
Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Treatment of Dry Eye Disease
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
  • Active Comparator: 1
    Intervention: Drug: Restasis, Refresh Plus
  • Placebo Comparator: 2
    Intervention: Drug: Restasis, Refresh Plus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2008
Not Provided

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.
Both
13 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00567177
HSC-MS-07-0421
Not Provided
Richard Yee, MD, Hermann Eye Center
Innovative Medical
Not Provided
Principal Investigator: Richard Yee, MD Hermann Eye Center
Innovative Medical
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP