Back to resultsBarrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Systane® Ultra
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dry Eye Signs, barrier function
Eligibility Criteria
Inclusion Criteria:
- Patients must have moderate corneal staining and exhibit a need to use artificial tears.
Exclusion Criteria:
- Patients can not participate in any other ophthalmic drug or device clinical trial within 30 days of the baseline visit.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Systane® Ultra
Arm Description
Outcomes
Primary Outcome Measures
Percent change from baseline of corneal fluorescein
Secondary Outcome Measures
Adverse event occurence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00946777
Brief Title
Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days
Official Title
Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (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
The primary objective is to determine if there is a correlation between reductions in corneal staining and improvements in corneal barrier function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry Eye Signs, barrier function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane® Ultra
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Systane® Ultra
Intervention Description
Systane® Ultra 1-2 drops, 4 times per day for 30 days
Primary Outcome Measure Information:
Title
Percent change from baseline of corneal fluorescein
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Adverse event occurence
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have moderate corneal staining and exhibit a need to use artificial tears.
Exclusion Criteria:
Patients can not participate in any other ophthalmic drug or device clinical trial within 30 days of the baseline visit.
12. IPD Sharing Statement
Citations:
PubMed Identifier
26170605
Citation
Fernandez KB, Epstein SP, Raynor GS, Sheyman AT, Massingale ML, Dentone PG, Landegger LD, Asbell PA. Modulation of HLA-DR in dry eye patients following 30 days of treatment with a lubricant eyedrop solution. Clin Ophthalmol. 2015 Jun 24;9:1137-45. doi: 10.2147/OPTH.S81355. eCollection 2015.
Results Reference
result
Learn more about this trial
Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days
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