Safety/Efficacy of Systane Free vs Refresh Tears - Full Text View

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00348322

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

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

Study placed in the following topic categories:

Lacerations
Tetrahydrozoline

ClinicalTrials.gov processed this record on January 14, 2009