Clinical Outcomes Following Treatment With SYSTANE® BALANCE

Study Overview
=================
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.

Official Title
-----------------
Clinical Evaluation Following Use of SYSTANE® BALANCE in Subjects With Lipid-Deficient Dry Eye

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Propylene glycol, 0.6% eye drops
* Other: Lubricant eye drops


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYSTANE BALANCE<br>Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days | Other: Propylene glycol, 0.6% eye drops<br> <br> * Other names: SYSTANE® BALANCE;|
| Active Comparator: REFRESH OPTIVE<br>Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days | Other: Lubricant eye drops<br> <br> * Other names: REFRESH OPTIVE® Advanced;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day 0), Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day 0), Day 35 | 
| 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. | Day 35 | 
| 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. | Baseline (Day 0), Day 35 |