Safety/Efficacy of Systane Free vs Refresh Liquigel

NCT ID: NCT00348517

Last Updated: 2012-03-05

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-11-30

Brief Summary

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The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.

Detailed Description

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Conditions

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Dry Eye

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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Systane

Group Type EXPERIMENTAL

Systane Free Lubricant Eye Drops

Intervention Type OTHER

1-2 drops per eye four times per day for 42 days

Refresh

Group Type ACTIVE_COMPARATOR

Refresh Liquigel Lubricant Eye Drops

Intervention Type OTHER

1-2 drops per eye four times per day for 42 days

Interventions

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Systane Free Lubricant Eye Drops

1-2 drops per eye four times per day for 42 days

Intervention Type OTHER

Refresh Liquigel Lubricant Eye Drops

1-2 drops per eye four times per day for 42 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \>/= 3 corneal staining score using NEI scoring system.
* Need artificial tears at least some of the time.

Exclusion Criteria

* History or evidence of ocular or intraocular surgery in either eye within the past six months.
* History of intolerance or hypersensitivity to any component of the study medication.
* Use of Restasis within 30 days of Visit 1.
* Participation in an investigational drug or device study within 30 days of entering this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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C-05-45

Identifier Type: -

Identifier Source: org_study_id

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