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

Alcon Research91 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dry Eye Syndrome Lipid Deficiency

Interventions

SYSTANE® BALANCE eyedropsOTHER

Minims® Saline 0.9% eyedropsOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mean Bulbar Conjunctival Staining

The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.

Time frame: Month 1

Secondary Outcomes

High Contrast logMAR Time Controlled Visual Acuity (TCVA)

TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.

Time frame: Month 1

Non Invasive Tear Film Break-up-time (NIBUT)

NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.

Time frame: Month 1

Data from ClinicalTrials.gov

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