Clinical Outcomes Following Treatment With SYSTANE® BALANCE

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776670
• Other study ID #: EXB107-P001
• Status: Completed
• Phase: N/A
• Start date: July 29, 2016
• Est. completion date: November 22, 2017

Study information

• Verified date: March 2019
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: November 22, 2017
• Est. primary completion date: November 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Propylene glycol, 0.6% eye drops

• Lubricant eye drops

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Results from the Novartis Clinical Trial Results Website