Back to resultsSafety/Efficacy of Systane Free vs Refresh Liquigel
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Systane Free Lubricant Eye Drops
Refresh Liquigel Lubricant Eye Drops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria: >/= 3 corneal staining score using NEI scoring system. Need artificial tears at least some of the time. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: History or evidence of ocular or intraocular surgery in either eye within the past six months. History of intolerance or hypersensitivity to any component of the study medication. Use of Restasis within 30 days of Visit 1. Participation in an investigational drug or device study within 30 days of entering this study. Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Systane
Refresh
Arm Description
Outcomes
Primary Outcome Measures
Change in corneal staining at Day 28 from baseline (Day 0)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00348517
Brief Title
Safety/Efficacy of Systane Free vs Refresh Liquigel
Official Title
An Evaluation of the Safety and Efficacy of Systane Free FID 105783
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 when compared to Refresh Liquigel 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
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane
Arm Type
Experimental
Arm Title
Refresh
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Systane Free Lubricant Eye Drops
Intervention Description
1-2 drops per eye four times per day for 42 days
Intervention Type
Other
Intervention Name(s)
Refresh Liquigel Lubricant Eye Drops
Intervention Description
1-2 drops per eye four times per day for 42 days
Primary Outcome Measure Information:
Title
Change in corneal staining at Day 28 from baseline (Day 0)
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>/= 3 corneal staining score using NEI scoring system.
Need artificial tears at least some of the time.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
History or evidence of ocular or intraocular surgery in either eye within the past six months.
History of intolerance or hypersensitivity to any component of the study medication.
Use of Restasis within 30 days of Visit 1.
Participation in an investigational drug or device study within 30 days of entering this study.
Other protocol-defined exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Safety/Efficacy of Systane Free vs Refresh Liquigel
We'll reach out to this number within 24 hrs