Back to resultsAcute Comfort of Lubricant Eye Drops FID 112903
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lubricant Eye Drops FID 112903
Optive Lubricant Eye Drops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dry eye, Artificial tear
Eligibility Criteria
Inclusion Criteria:
- Documented diagnosis of dry eye
- Must not have worn contact lenses for 1 week preceding enrollment
Exclusion Criteria:
- Age related
Sites / Locations
- Mansfield
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lubricant Eye Drops FID 112903
Optive Lubricant Eye Drops
Arm Description
Lubricant Eye Drops FID 112903 1 drop each eye one time
Optive Lubricant Eye Drops 1 drop each eye 1 time
Outcomes
Primary Outcome Measures
Drop Comfort Upon Instillation
Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00673855
Brief Title
Acute Comfort of Lubricant Eye Drops FID 112903
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 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 the acute comfort and blurring profile between two 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 tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lubricant Eye Drops FID 112903
Arm Type
Experimental
Arm Description
Lubricant Eye Drops FID 112903 1 drop each eye one time
Arm Title
Optive Lubricant Eye Drops
Arm Type
Active Comparator
Arm Description
Optive Lubricant Eye Drops 1 drop each eye 1 time
Intervention Type
Other
Intervention Name(s)
Lubricant Eye Drops FID 112903
Intervention Description
Lubricant Eye Drops FID 112903 1 drop each eye 1 time
Intervention Type
Other
Intervention Name(s)
Optive Lubricant Eye Drops
Intervention Description
Optive Lubricant Eye Drops
Primary Outcome Measure Information:
Title
Drop Comfort Upon Instillation
Description
Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.
Time Frame
Three minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented diagnosis of dry eye
Must not have worn contact lenses for 1 week preceding enrollment
Exclusion Criteria:
Age related
Facility Information:
Facility Name
Mansfield
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
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Acute Comfort of Lubricant Eye Drops FID 112903
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