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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00347984
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : April 10, 2012
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

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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
Drug Information available for: Systane

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

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00347984

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United States, Massachusetts
Andover, Massachusetts, United States, 01845
Sponsors and Collaborators
Alcon Research
ORA, Inc.
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Study Director: Mike Christensen Alcon Research
Layout table for additonal information Identifier: NCT00347984    
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:
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Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions