Safety/Efficacy of Systane Free vs Refresh Liquigel

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: Systane Free Lubricant Eye Drops; Other: Refresh Liquigel Lubricant Eye Drops

• Registration Number: NCT00348517
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study Start: 2006-07
• Study First Posted: 2006-07-04
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-02
• Last Update Posted: 2012-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systane	Systane Free Lubricant Eye Drops	-
Refresh	Refresh Liquigel Lubricant Eye Drops	-

Primary Outcome Measures

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