In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients

Alcon Research19 enrolled

Overview

The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.

The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Eye Syndrome

Interventions

SYSTANE® Gel Drop lubricant eye gelOTHER

SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Subjects must have history of dry eye as determined by: 1. Questionnaire 2. Tear Film Break Up Time less than or equal to 10 seconds 3. Schirmer's score of less than or equal to 5 mm 4. Corneal staining greater than or equal to 3 in either eye, and 5. Positive for conjunctival staining (greater than or equal to 1) Exclusion Criteria: * Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.

Outcomes

Primary Outcomes

Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.

The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.

Time frame: baseline and 28 days

Data from ClinicalTrials.gov

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