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Safety/Efficacy of Systane Free vs Refresh Liquigel

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00348517
First Posted: July 4, 2006
Last Update Posted: March 5, 2012
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.
Information provided by (Responsible Party):
Alcon Research
  Purpose
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 Intervention
Dry Eye Other: Systane Free Lubricant Eye Drops Other: Refresh Liquigel Lubricant Eye Drops

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

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

Enrollment: 100
Study Start Date: July 2006
Estimated Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00348517     History of Changes
Other Study ID Numbers: C-05-45
First Submitted: June 30, 2006
First Posted: July 4, 2006
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