Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease
Sponsor
Innovative Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT00567177
Collaborator
(none)
40
1
2
5
8
Study Details
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 |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Anticipated 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
:
Nov 1, 2007
Actual Study Completion Date
:
Apr 1, 2008
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
- Dry Eye disease [6 months]
Secondary Outcome Measures
- efficacy [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
13 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00567177
Other Study ID Numbers:
- HSC-MS-07-0421
First Posted:
Dec 4, 2007
Last Update Posted:
Jul 30, 2010
Last Verified:
Jul 1, 2010
Additional relevant MeSH terms: