Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-11-30

Brief Summary

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The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.

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Detailed Description

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Conditions

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Dry Eye Syndrome Lipid Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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SYSTANE BALANCE

SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month

Group Type EXPERIMENTAL

SYSTANE® BALANCE eyedrops

Intervention Type OTHER

Minims Saline

Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month

Group Type ACTIVE_COMPARATOR

Minims® Saline 0.9% eyedrops

Intervention Type OTHER

Interventions

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SYSTANE® BALANCE eyedrops

Intervention Type OTHER

Minims® Saline 0.9% eyedrops

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Non-contact lens wearer;
* Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
* Lipid deficiency;
* Best visual acuity of 6/9 or better in each eye;
* Willingness to adhere to the instructions set in the clinical protocol;
* Signature of the subject informed consent form;

Exclusion Criteria

* Use of systemic medication which might produce dry eye side effects;
* Systemic disease which might produce dry eye side effects;
* Active or recent ocular inflammation or infection;
* Use of ocular medication;
* Significant ocular anomaly;
* Previous ocular surgery;
* Previous use of Restasis;
* Any medical condition that might be prejudicial to the study;
* Pregnant or lactating;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No