Clinical Outcomes Following Treatment With SYSTANE® BALANCE

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-29

Study Completion Date

2017-11-22

Brief Summary

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The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.

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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 BALANCE

Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days

Group Type EXPERIMENTAL

Propylene glycol, 0.6% eye drops

Intervention Type OTHER

REFRESH OPTIVE

Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days

Group Type ACTIVE_COMPARATOR

Lubricant eye drops

Intervention Type OTHER

Interventions

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Propylene glycol, 0.6% eye drops

Intervention Type OTHER

Lubricant eye drops

Intervention Type OTHER

Other Intervention Names

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SYSTANE® BALANCE REFRESH OPTIVE® Advanced

Eligibility Criteria

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Inclusion Criteria

* Willing and able to attend all study visits;
* Must sign an informed consent form;
* Best-corrected visual acuity (BCVA) of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart;
* Willing to take study products as directed for entire study;

Exclusion Criteria

* Women of childbearing potential who are pregnant, plan to become pregnant during the study, breast feeding, or not using adequate birth control methods;
* Contact lens use within 30 days prior to Screening Visit, or unwilling to avoid contact lens use during the course of the study;
* Use of medication excluded by the protocol;
* Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
* Ocular surgeries or procedures excluded by the protocol;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No