Clinical Evaluation of Systane® Balance in Dry Eye Subjects

Alcon Research14 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.

This study was conducted in India.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Eye

Interventions

Propylene Glycol 0.6% eye dropsOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Sign informed consent and willing and able to attend all study visits; * Dry eye in both eyes diagnosed by an ophthalmologist; * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Women of childbearing potential who are pregnant or breastfeeding; * Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study; * Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening; * Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening; * Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening; * Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study; * Other protocol-specified exclusion criteria may apply.

Outcomes

Primary Outcomes

Change From Baseline in Corneal Staining Total Score

The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).

Time frame: Baseline (Day 0), Day 45, Day 90

Data from ClinicalTrials.gov

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