Product Preference With Systane Compared to Artificial Tears on Frequency of Drop Use

This study has been completed.
Sponsor:
Collaborator:
ORA, Inc.
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00347984
First received: June 30, 2006
Last updated: April 7, 2012
Last verified: August 2008
  Purpose

The objective of this study was to evaluate the effect of Systane® compared to marketed artificial tears on the frequency of drop use.


Condition Intervention
Dry Eye
Other: Systane Lubricant eye drops

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Systane® Compared to Marketed Artificial Tears on Frequency of Drop Use

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Frequency of drop use and/or desire to use; Drop preference

Secondary Outcome Measures:
  • Product questionnaire; Symptoms; Corneal and conjunctival staining; Tear film break-up time (TFBUT).

Estimated Enrollment: 50
Study Start Date: December 2005
Study Completion Date: February 2006
Primary Completion Date: February 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:

  • Subjects age 18 (minimum); reported history of dry eye syndrome in both eyes; TFBUT ≤ 7 seconds in at least 1 eye at Visit 1; ≥ 1+ fluorescein staining score in any region in at least 1 eye at Visit 1; desire to use an artificial tear substitute for dry eye symptoms at least 4 times per day at Visit 1 and Visit 2.

Exclusion Criteria:

  • Age less than 18 years
  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: NCT00347984

Locations
United States, Massachusetts
Maryland
Andover, Massachusetts, United States, 01845
Sponsors and Collaborators
Alcon Research
ORA, Inc.
Investigators
Study Director: Mike Christensen Alcon Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00347984     History of Changes
Other Study ID Numbers: 05-004-09
Study First Received: June 30, 2006
Last Updated: April 7, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 01, 2014