Product Preference With Systane Compared to Artificial Tears on Frequency of Drop Use
April 7, 2012 updated by: Alcon Research
The Effect of Systane® Compared to Marketed Artificial Tears on Frequency of Drop Use
The objective of this study was to evaluate the effect of Systane® compared to marketed artificial tears on the frequency of drop use.
Study Overview
Study Type
Interventional
Enrollment
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Andover, Massachusetts, United States, 01845
- Maryland
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Frequency of drop use and/or desire to use; Drop preference
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Secondary Outcome Measures
Outcome Measure |
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Product questionnaire; Symptoms; Corneal and conjunctival staining; Tear film break-up time (TFBUT).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Mike Christensen, Alcon Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
February 1, 2006
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
June 30, 2006
First Submitted That Met QC Criteria
July 3, 2006
First Posted (Estimate)
July 4, 2006
Study Record Updates
Last Update Posted (Estimate)
April 10, 2012
Last Update Submitted That Met QC Criteria
April 7, 2012
Last Verified
August 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-004-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.