Treatment of Dry Eye Disease Clinical Trial
Official title:
Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease
| Verified date | July 2010 |
| Source | Innovative Medical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
We propose to investigate the response to Restasis, over a prolonged period of time in heavy computer users with dry eye disease.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | April 2008 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 13 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Hermann Eye Center | 6400 Fannin Ste 1800 | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Innovative Medical |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Dry Eye disease | 6 months | No | |
| Secondary | efficacy | 6 months | No |