Evaluation of the Efficacy of an Ocular Emulsion on the Signs and Symptoms of Meibomian Gland Dysfunction

This investigation will involve approximately 90 MGD subjects, randomly assigned to either the Systane Balance treatment group or a control group using Optive™ Lubricant Eyedrops (Allergan), a low-viscosity artificial tear. Both arms will dose the drops four times per day and the treatment trial will be conducted for 6 months. The age range will be 18 years and older, with no upper age limit. Standard diagnostic tests for dry eye, as recommended by the NEI-Industry Workshop report,8 but with updated criteria in some instances, will be used to define clinical dry eye of the MGD sub-type. The three major tests will be: symptoms using a validated questionnaire (Schein), evidence of ocular surface damage, and demonstration of tear instability. The subjects will be enrolled if they consent and are confirmed as MGD subjects using the established clinical criteria used at SCCO of gland dropout Grade 1 per lower eyelid using meiboscopy,6, 9 or secretion quality Grade 1 in any of the three sectors (temporal, central, nasal) upon gland expression9, 10 using the recently developed Korb device.11 The principal outcome measure will be the tear film breakup time (TBUT), in seconds, at two hours post drop instillation. The two-hour TBUT value will be used to compare the control and test formulation at baseline and visits 3, 5 and 7. TBUT will be measured using 2.0 l of 1.0% NaFl. Exploratory outcome measures will include TBUT (seconds; change over time), corneal staining (change over time; 0 - 20 scale), symptoms (Schein and MGD-specific preliminary questionnaire score), drop comfort, Surface Regularity Index (a measure of surface disruption), lipid layer grade (1 - 5 Yokoi scale), meibum excreta quality, gland drop out and lid margin appearance all monitored as the change over time from baseline. Treatment comparisons will be made at each timepoint