Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00567177

Enrollment

Registered

2007-12-04

Start date

2007-11-30

Completion date

2008-04-30

Last updated

2010-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of Dry Eye Disease

Brief summary

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

Interventions

DRUGRestasis, 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Dry Eye disease	6 months

Secondary

Measure	Time frame
efficacy	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026