Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects

NCT ID: NCT01086774

Last Updated: 2012-02-02

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

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Brief Summary

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Evaluation of the optical effects of Systane Ultra

Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Systane Ultra

Systane Ultra Lubricant Eye Drops

Group Type EXPERIMENTAL

Systane Ultra Lubricant Eye Drops

Intervention Type OTHER

Single drop in both eyes

Interventions

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Systane Ultra Lubricant Eye Drops

Single drop in both eyes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or more.
2. Subjects must have Tear Break Up Time (TBUT) \< 5 seconds
3. Subjects must have a maximum blink interval (MBI) \< 10 seconds
4. Subjects must be willing to comply with all study requirements.
5. Subjects must understand, sign and be given a copy of the written Informed Consent form.

2. Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
3. Subjects with known sensitivity to planned study concomitant medications
4. Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
5. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SMA-09-39

Identifier Type: -

Identifier Source: org_study_id

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