Clinical Outcomes Following Treatment With SYSTANE® BALANCE

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Other: Propylene glycol, 0.6% eye drops; Other: Lubricant eye drops

• Study Type: Interventional
• Enrollment (Actual): 308
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYSTANE BALANCE; 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; Other Names: SYSTANE® BALANCE
Active Comparator: REFRESH OPTIVE; Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days	Other: Lubricant eye drops; 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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Project Manager, PLS, Alcon, a Novartis Company

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2016
• Primary Completion (Actual): November 22, 2017
• Study Completion (Actual): November 22, 2017

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: EXB107-P001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No