Safety/Efficacy of Systane Free vs Refresh Liquigel

Alcon

Status: Completed

Conditions: Dry Eye

Treatments: Other: Refresh Liquigel Lubricant Eye Drops; Other: Systane Free Lubricant Eye Drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT00348517

C-05-45

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Systane

Experimental group

Treatment:

Other: Systane Free Lubricant Eye Drops

Refresh

Active Comparator group

Treatment:

Other: Refresh Liquigel Lubricant Eye Drops