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Topical Cyclosporine and Disease Progression

NCT ID: NCT00567983

Last Updated: 2008-09-25

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.

Detailed Description

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Conditions

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Disease Progression Disease Severity Staining Schirmers OSDI

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

Intervention Type DRUG

Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily

2.

Group Type PLACEBO_COMPARATOR

Endura

Intervention Type DRUG

Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily

Interventions

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Restasis

Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily

Intervention Type DRUG

Endura

Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mild to Moderate dry eye symptoms

Exclusion Criteria

* Current use of Restasis
Minimum Eligible Age

18 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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Lakeside Eye Clinic

Principal Investigators

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Sanjay Rao

Role: PRINCIPAL_INVESTIGATOR

Lakeside Eye Clinic

Locations

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Lakeside Eye Clinic

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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13717A

Identifier Type: -

Identifier Source: org_study_id