Back to resultsClinical Outcomes Following Treatment With SYSTANE® BALANCE
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Propylene glycol, 0.6% eye drops
Lubricant eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Willing and able to attend all study visits;
- Must sign an informed consent form;
- Best-corrected visual acuity (BCVA) of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart;
- Willing to take study products as directed for entire study;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Women of childbearing potential who are pregnant, plan to become pregnant during the study, breast feeding, or not using adequate birth control methods;
- Contact lens use within 30 days prior to Screening Visit, or unwilling to avoid contact lens use during the course of the study;
- Use of medication excluded by the protocol;
- Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
- Ocular surgeries or procedures excluded by the protocol;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SYSTANE BALANCE
REFRESH OPTIVE
Arm Description
Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35
TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.
Secondary Outcome Measures
Change From Baseline in TFBUT at Day 35
TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.
Lipid Layer Thickness (LLT) Area Under the Curve (AUC120) at Day 35
LLT was measured using the LipiView® Ocular Surface Interferometer, an ophthalmic imaging device intended for use in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. Using these images, the LipiView® Interferometer measures the absolute thickness of the tear film lipid layer.
Mean Change From Baseline in Global Ocular Discomfort Visual Analog Scale (VAS) Score at Day 35
Ocular discomfort frequency and severity (each graded on a separate 100-units scale) were assessed using a visual analog scale (VAS). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past week' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past week' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for the given visit, as the square root of the product of the ocular discomfort frequency score multiplied by the ocular discomfort severity score. Improvement results in a reduction of the ocular discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02776670
Brief Title
Clinical Outcomes Following Treatment With SYSTANE® BALANCE
Official Title
Clinical Evaluation Following Use of SYSTANE® BALANCE in Subjects With Lipid-Deficient Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 29, 2016 (Actual)
Primary Completion Date
November 22, 2017 (Actual)
Study Completion Date
November 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.
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
308 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SYSTANE BALANCE
Arm Type
Experimental
Arm Description
Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
Arm Title
REFRESH OPTIVE
Arm Type
Active Comparator
Arm Description
Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days
Intervention Type
Other
Intervention Name(s)
Propylene glycol, 0.6% eye drops
Other Intervention Name(s)
SYSTANE® BALANCE
Intervention Type
Other
Intervention Name(s)
Lubricant eye drops
Other Intervention Name(s)
REFRESH OPTIVE® Advanced
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35
Description
TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.
Time Frame
Baseline (Day 0), Day 35
Secondary Outcome Measure Information:
Title
Change From Baseline in TFBUT at Day 35
Description
TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.
Time Frame
Baseline (Day 0), Day 35
Title
Lipid Layer Thickness (LLT) Area Under the Curve (AUC120) at Day 35
Description
LLT was measured using the LipiView® Ocular Surface Interferometer, an ophthalmic imaging device intended for use in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. Using these images, the LipiView® Interferometer measures the absolute thickness of the tear film lipid layer.
Time Frame
Day 35
Title
Mean Change From Baseline in Global Ocular Discomfort Visual Analog Scale (VAS) Score at Day 35
Description
Ocular discomfort frequency and severity (each graded on a separate 100-units scale) were assessed using a visual analog scale (VAS). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past week' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past week' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for the given visit, as the square root of the product of the ocular discomfort frequency score multiplied by the ocular discomfort severity score. Improvement results in a reduction of the ocular discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.
Time Frame
Baseline (Day 0), Day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing and able to attend all study visits;
Must sign an informed consent form;
Best-corrected visual acuity (BCVA) of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart;
Willing to take study products as directed for entire study;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Women of childbearing potential who are pregnant, plan to become pregnant during the study, breast feeding, or not using adequate birth control methods;
Contact lens use within 30 days prior to Screening Visit, or unwilling to avoid contact lens use during the course of the study;
Use of medication excluded by the protocol;
Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
Ocular surgeries or procedures excluded by the protocol;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager, PLS
Organizational Affiliation
Alcon, a Novartis Company
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Outcomes Following Treatment With SYSTANE® BALANCE
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