Safety/Efficacy of Systane Free vs Refresh Tears

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00348322
First received: June 30, 2006
Last updated: September 23, 2008
Last verified: September 2008
  Purpose

The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 in comparison to Refresh Tears Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.


Condition Intervention
Dry Eye
Drug: Systane Free Lubricant Eye Drops

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Evaluation of the Safety and Efficacy of Systane Free FID 105783 - II

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal Staining change from baseline

Secondary Outcome Measures:
  • Comfort, Conjunctival Staining

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > = 3 stain using NEI grid and need artificial tears at least some of the time.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348322

Locations
United States, Texas
El Paso Facility
El Paso, Texas, United States, 79904
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Mike Christensen Alcon Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00348322     History of Changes
Other Study ID Numbers: C-06-22
Study First Received: June 30, 2006
Last Updated: September 23, 2008
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013