To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops

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

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-06-30

Brief Summary

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This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.

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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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Systane

Systane Lubricant Eye Drops

Group Type EXPERIMENTAL

Systane

Intervention Type OTHER

Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day)

Refresh Tears

Refresh Tears Lubricant Eye Drops

Group Type EXPERIMENTAL

Refresh Tears

Intervention Type OTHER

Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)

Interventions

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Systane

Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day)

Intervention Type OTHER

Refresh Tears

Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question.
* A sodium fluorescein corneal staining sum of ≥ 3 in either eye.
* A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart.

Exclusion Criteria

* A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
* Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study.
* A history of intolerance or hypersensitivity to any component of the study medications.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No