Artificial Tears Study in Mild to Moderate Dry Eye Patients

NCT ID: NCT00607776

Last Updated: 2025-02-03

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

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-04-30

Brief Summary

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The mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.

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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1

Systane

Group Type ACTIVE_COMPARATOR

Systane

Intervention Type DRUG

Drops

2

Blink tears

Group Type EXPERIMENTAL

(9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400

Intervention Type DRUG

Drops

Interventions

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(9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400

Drops

Intervention Type DRUG

Systane

Drops

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mild to moderate dry eye
* over 18

Exclusion Criteria

* No concurrent ocular disease or meds
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Medical Optics

INDUSTRY

Sponsor Role lead

Responsible Party

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AMO, Inc.

Principal Investigators

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Eric Donnenfeld, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Long Island

Other Identifiers

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PEGT-104-9582

Identifier Type: -

Identifier Source: org_study_id

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