Back to resultsTo Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Systane
Refresh Tears
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Systane, Refresh Tears, Dry Eye, Moderate to Severe Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question.
- A sodium fluorescein corneal staining sum of ≥ 3 in either eye.
- A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart.
Exclusion Criteria:
- A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
- Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study.
- A history of intolerance or hypersensitivity to any component of the study medications.
Sites / Locations
- Vasan Eye Care Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Systane
Refresh Tears
Arm Description
Systane Lubricant Eye Drops
Refresh Tears Lubricant Eye Drops
Outcomes
Primary Outcome Measures
To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye.
This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01160133
Brief Title
To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (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
This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Systane, Refresh Tears, Dry Eye, Moderate to Severe Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane
Arm Type
Experimental
Arm Description
Systane Lubricant Eye Drops
Arm Title
Refresh Tears
Arm Type
Experimental
Arm Description
Refresh Tears Lubricant Eye Drops
Intervention Type
Other
Intervention Name(s)
Systane
Intervention Description
Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day)
Intervention Type
Other
Intervention Name(s)
Refresh Tears
Intervention Description
Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)
Primary Outcome Measure Information:
Title
To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye.
Description
This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3.
Time Frame
Baseline to visit 3 (Day 42)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question.
A sodium fluorescein corneal staining sum of ≥ 3 in either eye.
A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart.
Exclusion Criteria:
A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study.
A history of intolerance or hypersensitivity to any component of the study medications.
Facility Information:
Facility Name
Vasan Eye Care Hospital
City
Saidapet
State/Province
Channai
ZIP/Postal Code
600 015
Country
India
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops
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