Safety and Tolerability of Artificial Tears in Dry Eye Subjects

NCT ID: NCT00932477

Last Updated: 2015-08-26

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

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-09-30

Brief Summary

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The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. The subject will use one product at a time for a duration of one week before switching to the next assigned product.

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

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Artificial Tear Formulation 1

Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear

Group Type EXPERIMENTAL

Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear

Intervention Type DRUG

1 to 2 drops into each eye three times per day

Artificial Tear Formulation 2

Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear

Group Type EXPERIMENTAL

Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear

Intervention Type DRUG

1 to 2 drops into each eye three times per day

Glycerin and Polysorbate 80 based artificial tear

Glycerin and Polysorbate 80 based artificial tear

Group Type ACTIVE_COMPARATOR

Glycerin and Polysorbate 80 based artificial tear

Intervention Type DRUG

1 to 2 drops into each eye three times per day

Interventions

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Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear

1 to 2 drops into each eye three times per day

Intervention Type DRUG

Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear

1 to 2 drops into each eye three times per day

Intervention Type DRUG

Glycerin and Polysorbate 80 based artificial tear

1 to 2 drops into each eye three times per day

Intervention Type DRUG

Other Intervention Names

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Refresh Dry Eye Therapy®

Eligibility Criteria

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Inclusion Criteria

* Mild, moderate or severe symptoms of dry eye

Exclusion Criteria

* Uncontrolled systemic disease
* Contact lens wear
* Participation in another clinical study
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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Responsibility Role SPONSOR

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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AG9965-001

Identifier Type: -

Identifier Source: org_study_id

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