Back to resultsAcute Comfort and Blur of Systane and Optive
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Systane Lubricant Eye Drops
Optive Lubricant Eye Drops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dry eye
Eligibility Criteria
Inclusion Criteria:
- Healthy, normal eyes OR documented diagnosis of dry eye
Exclusion Criteria:
- Must not have worn contact lenses for 7 days preceding enrollment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Systane Lubricant Eye Drops
Optive Lubricant Eye Drops
Arm Description
Systane Lubricant Eye Drops 1 drop in each eye one time
Optive Lubricant Eye Drops 1 drop each one time
Outcomes
Primary Outcome Measures
Visual Blur
Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00568386
Brief Title
Acute Comfort and Blur of Systane and Optive
Official Title
Acute Comfort and Blurring Profile Evaluation Comparing Systane Lubricant Eye Drops to Optive Lubricant Eye Drops
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (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, preference and blur profile between two marketed artificial tears in both dry eye and non-dry eye patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane Lubricant Eye Drops
Arm Type
Experimental
Arm Description
Systane Lubricant Eye Drops 1 drop in each eye one time
Arm Title
Optive Lubricant Eye Drops
Arm Type
Active Comparator
Arm Description
Optive Lubricant Eye Drops 1 drop each one time
Intervention Type
Other
Intervention Name(s)
Systane Lubricant Eye Drops
Intervention Description
Systane Lubricant Eye Drops 1 drop each eye once time
Intervention Type
Other
Intervention Name(s)
Optive Lubricant Eye Drops
Intervention Description
Optive Lubricant Eye Drops 1 drop each eye one time
Primary Outcome Measure Information:
Title
Visual Blur
Description
Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes.
Time Frame
3 minutes post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, normal eyes OR documented diagnosis of dry eye
Exclusion Criteria:
Must not have worn contact lenses for 7 days preceding enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Christensen
Organizational Affiliation
Alcon Research
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Acute Comfort and Blur of Systane and Optive
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