Safety/Efficacy of Systane Free vs Refresh Liquigel

Alcon Research100 enrolled

Overview

The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Dry Eye

Interventions

Systane Free Lubricant Eye DropsOTHER

1-2 drops per eye four times per day for 42 days

Refresh Liquigel Lubricant Eye DropsOTHER

1-2 drops per eye four times per day for 42 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \>/= 3 corneal staining score using NEI scoring system. * Need artificial tears at least some of the time. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * History or evidence of ocular or intraocular surgery in either eye within the past six months. * History of intolerance or hypersensitivity to any component of the study medication. * Use of Restasis within 30 days of Visit 1. * Participation in an investigational drug or device study within 30 days of entering this study. * Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Change in corneal staining at Day 28 from baseline (Day 0)

Time frame: Day 28

Data from ClinicalTrials.gov

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