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Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-007)

NCT ID: NCT00548301

Last Updated: 2011-07-01

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

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome.

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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cyclosporine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of moderate to severe dry eye syndrome with or without Sjogren's syndrome or other autoimmune disease

Exclusion Criteria

* Intraocular or refractive surgery in the study eye within 3 months prior to study start
* Unwilling to discontinue use of contact lenses during the run-in and duration of the study
* Pregnancy or lactation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sirion Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Roger Vogel, MD

Role: STUDY_CHAIR

Sirion Therapeutics

Locations

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Eye Center Northeast

Bangor, Maine, United States

Site Status

Countries

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United States

Other Identifiers

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ST-603-007

Identifier Type: -

Identifier Source: org_study_id

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