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Safety/Efficacy of Systane Free vs Refresh Liquigel

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ClinicalTrials.gov Identifier: NCT00348517
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : March 5, 2012
Sponsor:
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 ]


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

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
ClinicalTrials.gov 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
Tetrahydrozoline
Lubricant Eye Drops
Carboxymethylcellulose Sodium
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Laxatives
Gastrointestinal Agents