Back to resultsProduct Preference With Systane Compared to Artificial Tears on Frequency of Drop Use
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Systane Lubricant eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility 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
Sites / Locations
- Maryland
Outcomes
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).
Full Information
NCT ID
NCT00347984
First Posted
June 30, 2006
Last Updated
April 7, 2012
Sponsor
Alcon Research
Collaborators
ORA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00347984
Brief Title
Product Preference With Systane Compared to Artificial Tears on Frequency of Drop Use
Official Title
The Effect of Systane® Compared to Marketed Artificial Tears on Frequency of Drop Use
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
Collaborators
ORA, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Systane Lubricant eye drops
Primary Outcome Measure Information:
Title
Frequency of drop use and/or desire to use; Drop preference
Secondary Outcome Measure Information:
Title
Product questionnaire; Symptoms; Corneal and conjunctival staining; Tear film break-up time (TFBUT).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Christensen
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Maryland
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01845
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Product Preference With Systane Compared to Artificial Tears on Frequency of Drop Use
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