Back to resultsSafety/Efficacy of Systane Free vs Refresh Tears
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Systane Free Lubricant Eye Drops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria: > = 3 stain using NEI grid and need artificial tears at least some of the time.
Sites / Locations
- El Paso Facility
Outcomes
Primary Outcome Measures
Corneal Staining change from baseline
Secondary Outcome Measures
Comfort, Conjunctival Staining
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00348322
Brief Title
Safety/Efficacy of Systane Free vs Refresh Tears
Official Title
An Evaluation of the Safety and Efficacy of Systane Free FID 105783 - II
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 in comparison to Refresh Tears Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.
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
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Systane Free Lubricant Eye Drops
Primary Outcome Measure Information:
Title
Corneal Staining change from baseline
Secondary Outcome Measure Information:
Title
Comfort, Conjunctival Staining
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> = 3 stain using NEI grid and need artificial tears at least some of the time.
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
El Paso Facility
City
El Paso
State/Province
Texas
ZIP/Postal Code
79904
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety/Efficacy of Systane Free vs Refresh Tears
We'll reach out to this number within 24 hrs