Back to resultsComparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time
Primary Purpose
Dry Eye
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Systane Ultra
Optive
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dry eye or lubricant eye drops
Eligibility Criteria
Inclusion Criteria:
- Corrected VA of 0.6 LogMar or better OU
Exclusion:
- Topical ocular medication use
- Presence of Ocular conditions (blepharitis, conjunctival infections, etc)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Systane Ultra
Optive
Arm Description
Systane Ultra Lubricant Eye Drops
Optive Lubricant eye drops
Outcomes
Primary Outcome Measures
TBUT
Tear Film break-up time
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01417013
Brief Title
Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time
Official Title
A Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Management Decision
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is assess the Tear Film break-up time (TBUT) in mild to moderate dry eye subjects.
Detailed Description
The primary objective of this study is assess the tear film break-up time in mild to moderate dry eye subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry eye or lubricant eye drops
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane Ultra
Arm Type
Active Comparator
Arm Description
Systane Ultra Lubricant Eye Drops
Arm Title
Optive
Arm Type
Active Comparator
Arm Description
Optive Lubricant eye drops
Intervention Type
Other
Intervention Name(s)
Systane Ultra
Other Intervention Name(s)
Systane Ultra Lubricant Eye Drops
Intervention Description
Lubricant Eye Drops
Intervention Type
Other
Intervention Name(s)
Optive
Other Intervention Name(s)
Optive Lubricant eye drops
Intervention Description
Lubricant eye drops
Primary Outcome Measure Information:
Title
TBUT
Description
Tear Film break-up time
Time Frame
14 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Corrected VA of 0.6 LogMar or better OU
Exclusion:
Topical ocular medication use
Presence of Ocular conditions (blepharitis, conjunctival infections, etc)
12. IPD Sharing Statement
Learn more about this trial
Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time
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