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Efficacy and Acceptability of Two Lubricant Eye Drops

NCT ID: NCT00756678

Last Updated: 2011-10-31

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

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-08-31

Brief Summary

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Efficacy and acceptability of two new artificial tears following two weeks of treatment in patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then crossover to the alternate treatment for 7 days.

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

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Carboxymethylcellulose and Glycerin

Group Type ACTIVE_COMPARATOR

Lubricant Eye Drops (Optive™)

Intervention Type DRUG

1 drop in both eyes as needed for 7 days'

2

Polyethylene glycol 400

Group Type ACTIVE_COMPARATOR

Lubricating Eye Drops (blink® Tears)

Intervention Type DRUG

1 drop in both eyes as needed for 7 days

Interventions

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Lubricant Eye Drops (Optive™)

1 drop in both eyes as needed for 7 days'

Intervention Type DRUG

Lubricating Eye Drops (blink® Tears)

1 drop in both eyes as needed for 7 days

Intervention Type DRUG

Other Intervention Names

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Optive™ blink® Tears

Eligibility Criteria

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Inclusion Criteria

* Male or Female
* At least 18 years of age
* Current use of artificial tears

Exclusion Criteria

* Any uncontrolled systemic disease
* Pregnancy or planning a pregnancy
* Contact lens wear
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Chevy Chase, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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MA-OPT-08-001

Identifier Type: -

Identifier Source: org_study_id