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Safety/Efficacy of Systane Free vs Refresh Liquigel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00348517
First received: June 30, 2006
Last updated: March 2, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Evaluation of the Safety and Efficacy of Systane Free FID 105783

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00348517     History of Changes
Other Study ID Numbers: C-05-45
Study First Received: June 30, 2006
Last Updated: March 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tetrahydrozoline
Carboxymethylcellulose Sodium
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Laxatives
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013