The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects

Alcon

Status: Completed

Conditions: Dry Eye

Treatments: Other: Sodium chloride 0.9% saline solution; Other: Propylene glycol 0.6% ocular emulsion

Study type: Interventional

Funder types: Industry

Identifiers

NCT01718028

RDG-11-262

Details and patient eligibility

About

The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a day for 30 days to increase non-invasive tear film break up time over baseline, compared to a saline control, in dry eye subjects with lipid deficiency.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Read, sign, and date an information consent;
• Willing and able to follow instructions and maintain the appointment schedule;
• Best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed at Visit 1;
• Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
• Meet protocol-specified criteria for dry eye at Visit 1;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past six months;
• Current punctal occlusion of any type (e.g., collagen plugs, silicon plugs);
• History of intolerance or hypersensitivity to any component of the study medications;
• History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
• Use of any concomitant topical ocular medications during the study period;
• Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1;
• Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation;
• Unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
• Participation in an investigational drug or device study within 30 days of entering this study;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

SYSTANE® BALANCE

Experimental group

Description:

Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days

Treatment:

Other: Propylene glycol 0.6% ocular emulsion

LARMABAK®

Active Comparator group

Description:

Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days

Treatment:

Other: Sodium chloride 0.9% saline solution