Back to resultsAcute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Systane Ultra Lubricant Eye Drops
Optive Lubricant Eye Drops
Blink Tears
GenTeal Moderate Lubricant Eye Drops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dry Eye, Artificial Tears,
Eligibility Criteria
Inclusion Criteria:
- documented diagnosis of dry eye
Exclusion Criteria:
- use of topical ocular drops within 2 hours preceding enrollment
Sites / Locations
- Alcon Call Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
Systane Ultra Lubricant Eye Drops
Optive Lubricant Eye Drops
Blink Tears
GenTeal Moderate Lubricant Eye Drops
Arm Description
Systane Ultra Lubricant Eye Drops 1 drop each one time
Optive Lubricant Eye Drops 1 drop each eye one time
Blink Tears 1 drop each eye one time
GenTeal Moderate Lubricant Eye Drops 1 drop each eye one time
Outcomes
Primary Outcome Measures
Drop Comfort
Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00756093
Brief Title
Acute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (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
To evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry Eye, Artificial Tears,
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane Ultra Lubricant Eye Drops
Arm Type
Experimental
Arm Description
Systane Ultra Lubricant Eye Drops 1 drop each one time
Arm Title
Optive Lubricant Eye Drops
Arm Type
Active Comparator
Arm Description
Optive Lubricant Eye Drops 1 drop each eye one time
Arm Title
Blink Tears
Arm Type
Active Comparator
Arm Description
Blink Tears 1 drop each eye one time
Arm Title
GenTeal Moderate Lubricant Eye Drops
Arm Type
Active Comparator
Arm Description
GenTeal Moderate Lubricant Eye Drops 1 drop each eye one time
Intervention Type
Other
Intervention Name(s)
Systane Ultra Lubricant Eye Drops
Intervention Description
Systane Ultra Lubricant Eye Drops one drop each eye one time
Intervention Type
Other
Intervention Name(s)
Optive Lubricant Eye Drops
Intervention Description
Optive Lubricant Eye Drops one drop each eye one time
Intervention Type
Other
Intervention Name(s)
Blink Tears
Intervention Description
Blink Tears one drop each eye one time
Intervention Type
Other
Intervention Name(s)
GenTeal Moderate Lubricant Eye Drops
Intervention Description
GenTeal Moderate Lubricant Eye Drops one drop each eye one time
Primary Outcome Measure Information:
Title
Drop Comfort
Description
Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable.
Time Frame
once upon instillation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
documented diagnosis of dry eye
Exclusion Criteria:
use of topical ocular drops within 2 hours preceding enrollment
Facility Information:
Facility Name
Alcon Call Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops
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