Back to resultsEfficacy of Systane Ultra in Post Menopausal Women With Dry Eye
Primary Purpose
Post Menopausal Dry Eye Subjects
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Systane Ultra Lubricant Eye Drops
Sensitive Eyes Eye Drops (Bausch & Lomb)
Sponsored by
About this trial
This is an interventional supportive care trial for Post Menopausal Dry Eye Subjects focused on measuring Dry Eye, Post Menopausal dry eye
Eligibility Criteria
Inclusion Criteria:
- Post-menopausal (menses ceased more than 12 months prior to the start of the study).
- Diagnosed for dry eye
Exclusion Criteria:
- History of Sjögren's Syndrome or evidence of chronic dry eye syndrome. Confirmed autoimmune connective tissue diseases such as rheumatoid arthritis, fibromyalgia or scleroderma.
- Active and severe blepharitis, rosacea and associated ocular sequelae.
- Has any significant eyelid abnormality affecting lid function.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Systane Ultra
Sensitive Eyes
Arm Description
Systane Ultra Lubricant Eye Drops
Sensitive Eyes Eye Drops (Bausch & Lomb)
Outcomes
Primary Outcome Measures
Reduction in corneal staining
Secondary Outcome Measures
Patient acceptability / comfort
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01105910
Brief Title
Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
undefined (undefined)
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 efficacy of Systane Ultra in post menopausal women with dry eye.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Menopausal Dry Eye Subjects
Keywords
Dry Eye, Post Menopausal dry eye
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane Ultra
Arm Type
Experimental
Arm Description
Systane Ultra Lubricant Eye Drops
Arm Title
Sensitive Eyes
Arm Type
Active Comparator
Arm Description
Sensitive Eyes Eye Drops (Bausch & Lomb)
Intervention Type
Other
Intervention Name(s)
Systane Ultra Lubricant Eye Drops
Intervention Description
1 to 2 drops in each eye 4 times per day for 30 days
Intervention Type
Other
Intervention Name(s)
Sensitive Eyes Eye Drops (Bausch & Lomb)
Intervention Description
1 to 2 drops in each eye 4 times per day for 30 days
Primary Outcome Measure Information:
Title
Reduction in corneal staining
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Patient acceptability / comfort
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post-menopausal (menses ceased more than 12 months prior to the start of the study).
Diagnosed for dry eye
Exclusion Criteria:
History of Sjögren's Syndrome or evidence of chronic dry eye syndrome. Confirmed autoimmune connective tissue diseases such as rheumatoid arthritis, fibromyalgia or scleroderma.
Active and severe blepharitis, rosacea and associated ocular sequelae.
Has any significant eyelid abnormality affecting lid function.
12. IPD Sharing Statement
Citations:
Citation
http://www.aaopt.org/efficacy-evaluation-systane-ultra-lubricant-eye-drops-postmenopausal-women-dry-eye
Results Reference
result
Learn more about this trial
Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye
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