In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients

Not Applicable

Completed

• Conditions: Dry Eye Syndrome

• Registration Number: NCT01483989
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-02
• Status Verified: 2012-02
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.	baseline and 28 days	The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.