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

The Effect of SYSTANE® BALANCE on Non-Invasive Tear Film Break Up Time (NITFBUT) in Dry Eye Subjects With Lipid Deficiency Following 30 Days of Use

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.

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.