Clinical Outcomes Following Treatment With SYSTANE® BALANCE

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: Propylene glycol, 0.6% eye drops; Other: Lubricant eye drops

• Registration Number: NCT02776670
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-18
• Study Start: 2016-07-29
• Primary Completion: 2017-11-22
• Study Completion: 2017-11-22
• Results First Submitted: 2018-11-19
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-19
• Last Update Submitted: 2019-03-19
• Results First Posted: 2019-06-19
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SYSTANE BALANCE	Propylene glycol, 0.6% eye drops	Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
REFRESH OPTIVE	Lubricant eye drops	Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35	Baseline (Day 0), 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

Name	Time	Method
Change From Baseline in TFBUT at Day 35	Baseline (Day 0), 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	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	Baseline (Day 0), 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.