A Multi-Center Randomized Study to Evaluate the Efficacy and Safety of an Investigational Lubricant Eye Drop

NCT ID: NCT00243711

Last Updated: 2011-05-30

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

PHASE2/PHASE3

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-04-30

Brief Summary

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The efficacy, safety and acceptability of an investigational lubricant eye drop in subjects with dry eye will be evaluated in comparison with currently-available lubricant eye drops.

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

Interventions

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Carboxymethylcellulose sodium and Glycerin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mild, Moderate, or Severe Dry Eye Symptoms and current eye drop use;
* Reduced tear stability or tear production

Exclusion Criteria

* NONE
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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Mark Curtis, O.D.

Role: PRINCIPAL_INVESTIGATOR

InSight Eyecare

Locations

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Warrensburg, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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AG9689-001

Identifier Type: -

Identifier Source: org_study_id