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

Alcon

Status: Completed

Conditions: Lipid Deficiency; Dry Eye Syndrome

Treatments: Other: Minims® Saline 0.9% eyedrops; Other: SYSTANE® BALANCE eyedrops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01688726

A00977

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;
• Other protocol-defined inclusion criteria may apply.

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;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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91 participants in 2 patient groups

SYSTANE BALANCE

Experimental group

Description:

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

Treatment:

Other: SYSTANE® BALANCE eyedrops

Minims Saline

Active Comparator group

Description:

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

Treatment:

Other: Minims® Saline 0.9% eyedrops