Safety/Efficacy of Systane Free vs Refresh Liquigel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00348517
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : March 5, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Other: Systane Free Lubricant Eye Drops Other: Refresh Liquigel Lubricant Eye Drops Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Evaluation of the Safety and Efficacy of Systane Free FID 105783
Study Start Date : July 2006
Actual Primary Completion Date : November 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Systane Other: Systane Free Lubricant Eye Drops
1-2 drops per eye four times per day for 42 days
Active Comparator: Refresh Other: Refresh Liquigel Lubricant Eye Drops
1-2 drops per eye four times per day for 42 days

Primary Outcome Measures :
  1. Change in corneal staining at Day 28 from baseline (Day 0) [ Time Frame: Day 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Alcon Research Identifier: NCT00348517     History of Changes
Other Study ID Numbers: C-05-45
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Ophthalmic Solutions
Lubricant Eye Drops
Carboxymethylcellulose Sodium
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Gastrointestinal Agents