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Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

NCT ID: NCT00567177

Last Updated: 2010-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-04-30

Brief Summary

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

Detailed Description

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Conditions

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Treatment of Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Restasis, Refresh Plus

Intervention Type DRUG

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

2

Group Type PLACEBO_COMPARATOR

Restasis, Refresh Plus

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Innovative Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Hermann Eye Center

Principal Investigators

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Richard Yee, MD

Role: PRINCIPAL_INVESTIGATOR

Hermann Eye Center

Locations

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Hermann Eye Center

6400 Fannin Ste 1800, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-07-0421

Identifier Type: -

Identifier Source: org_study_id