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Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye

NCT ID: NCT00514852

Last Updated: 2009-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-01-31

Brief Summary

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The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear

Detailed Description

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Conditions

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Dry Eye Syndrome

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

Carboxymethylcellulose and Glycerin based artificial tear

Group Type EXPERIMENTAL

Carboxymethylcellulose and Glycerin based artificial tear

Intervention Type DRUG

1 to 2 drops into each eye as needed but at least twice daily

2

Carboxymethylcellulose

Group Type ACTIVE_COMPARATOR

Carboxymethylcellulose

Intervention Type DRUG

1 to 2 drops into each eye as needed but at least twice daily

Interventions

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Carboxymethylcellulose and Glycerin based artificial tear

1 to 2 drops into each eye as needed but at least twice daily

Intervention Type DRUG

Carboxymethylcellulose

1 to 2 drops into each eye as needed but at least twice daily

Intervention Type DRUG

Other Intervention Names

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Refresh Plus

Eligibility Criteria

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Inclusion Criteria

* Mild, moderate or Severe Symptoms of Dry Eye

Exclusion Criteria

* Uncontrolled systemic disease
* Use of systemic medications affecting dry eye
* Pregnancy or planning a pregnancy
* Contact lens wear
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Allergan, Inc.

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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AG9818-002

Identifier Type: -

Identifier Source: org_study_id