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

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ClinicalTrials.gov Identifier: NCT00347984
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : April 10, 2012
Sponsor:
Collaborator:
ORA, Inc.
Information provided by:
Alcon Research

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

Condition or disease Intervention/treatment Phase
Dry Eye Other: Systane Lubricant eye drops Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Systane® Compared to Marketed Artificial Tears on Frequency of Drop Use
Study Start Date : December 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00347984     History of Changes
Other Study ID Numbers: 05-004-09
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: August 2008

Additional relevant MeSH terms:
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions