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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
History of Changes
  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
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 May 22, 2013