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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014