SYSTANE® Family - Meibomian Deficiency

SYSTANE® Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects

The purpose of this study was to assess the efficacy of the SYSTANE® family of products (SYSTANE® Lid Wipes, SYSTANE® BALANCE Lubricant Eye Drops, and SYSTANE® Vitamins) on meibomian gland functionality in subjects with lipid deficiency related to evaporative dry eye as compared to the standard of care warm compresses.

Inclusion Criteria:

• Must have a clinical diagnosis of lipid deficient Evaporative Dry Eye;
• Meibomian Gland Functionality - Not more than 6 glands yielding liquid secretion;
• Must be willing to discontinue the use of all other Meibomian Gland; Dysfunction management prior to receiving the study test article at Visit 1, up until the end of the study period;
• Must have best corrected visual acuity of 20/40 Snellen or better in each eye;
• Must be able to follow instructions and be willing and able to attend required study visits;
• Must read, sign, and date an Ethics Committee reviewed and approved informed consent form;
• 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 6 months;
• Current punctal occlusion of any type (e.g., collagen plugs, silicone 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;
• Pregnant or lactating at the time of enrollment;
• Not willing to take adequate precautions not to become pregnant during the study;
• 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 that may preclude the safe administration of either drop under investigation;
• Unwilling to discontinue contact lens wear during the study period and for at least 1 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.