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Caroline A Blackie,1 Christy A Coleman,1 Kelly K Nichols,2 Lyndon Jones,3 Peter Q Chen,4 Ron Melton,5 David L Kading,6 Leslie E O’Dell,7 Sruthi Srinivasan3 1TearScience Inc., Morrisville, NC, 2School of Optometry, The University of Alabama at Birmingham, AB, USA; 3School of Optometry and Vision Science, University of Waterloo, Waterloo, ON, Canada; 4Clayton Eye Center, Morrow, GA, 5Charlotte Eye Ear Nose and Throat Associates, Charlotte, NC, 6Specialty Eyecare Group, Kirkland, WA, 7May Eye Care Center and Associates, Hanover, PA, USA Purpose: To evaluate the effect of a single vectored thermal pulsation (VTP) treatment in contact lens wearers with meibomian gland dysfunction (MGD) and dry eye symptoms.Methods: The prospective, nonsignificant risk, open-label, randomized, multi-center clinical trial included 55 soft contact lens (SCL) wearers with MGD and evaporative dry eye. Subjects were randomized to the single VTP treatment group or an untreated control. The controls received a crossover VTP treatment at 3 months (crossover treatment group). Primary effectiveness measures were meibomian gland secretion (MGS) score and Standard Patient Evaluation of Eye Dryness (SPEED) that were evaluated at baseline, at 1 and 3 months post-VTP treatment, and at 1 month post-VTP treatment in the crossover treatment group. Exploratory variables included fluorescein tear break-up time (TBUT), lid wiper epitheliopathy (LWE), lid parallel conjunctival folds (LIPCOF), ocular surface staining, frequency of over-the-counter (OTC) drop use, and hours of comfortable contact lens wear.Results: At 3 months, the treatment group showed significantly greater mean change from baseline in MGS (12.4±9.1 vs 1.4±6.4, p |
