Back to resultsObjective Measurements of Prolonged Effects of Restasis on Dry Eye Disease
Primary Purpose
Treatment of Dry Eye Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Restasis, Refresh Plus
Sponsored by
About this trial
This is an interventional treatment trial for Treatment of Dry Eye Disease
Eligibility 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.
Sites / Locations
- Hermann Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Dry Eye disease
Secondary Outcome Measures
efficacy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00567177
Brief Title
Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease
Official Title
Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Innovative Medical
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Restasis, Refresh Plus
Intervention Description
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
Primary Outcome Measure Information:
Title
Dry Eye disease
Time Frame
6 months
Secondary Outcome Measure Information:
Title
efficacy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Yee, MD
Organizational Affiliation
Hermann Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hermann Eye Center
City
6400 Fannin Ste 1800
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease
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