Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

Phase 4

Completed

• Conditions: Treatment of Dry Eye Disease
• Interventions: Drug: Restasis, Refresh Plus

• Registration Number: NCT00567177
• Lead Sponsor: Innovative Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-04
• Study Completion: 2008-04
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-29
• Last Update Posted: 2010-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Restasis, Refresh Plus	-
2	Restasis, Refresh Plus	-

Primary Outcome Measures

Name	Time	Method
Dry Eye disease	6 months

Secondary Outcome Measures

Name	Time	Method
efficacy	6 months

Trial Locations

Locations (1)

Hermann Eye Center; 🇺🇸 6400 Fannin Ste 1800, Texas, United States