Clinical Outcomes Following Treatment With SYSTANE® BALANCE

Alcon

Status: Completed

Conditions: Dry Eye

Treatments: Other: Propylene glycol, 0.6% eye drops; Other: Lubricant eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT02776670

EXB107-P001

Details and patient eligibility

About

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.

Enrollment: 308 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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308 participants in 2 patient groups

SYSTANE BALANCE

Experimental group

Description:

Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days

Treatment:

Other: Propylene glycol, 0.6% eye drops

REFRESH OPTIVE

Active Comparator group

Description:

Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days

Treatment:

Other: Lubricant eye drops