A single vectored thermal pulsation treatment for meibomian gland dysfunction increases mean comfortable contact lens wearing time by approximately 4 hours per day

Clinical Ophthalmology Dovepress open access to scientific and medical research C l i n i c a l T r i a l R e p o rt Clinical Ophthalmology downloaded from https://www.dovepress.com/ by 37.59.46.207 on 12-Jul-2018 For personal use only. Open Access Full Text Article A single vectored thermal pulsation treatment for meibomian gland dysfunction increases mean comfortable contact lens wearing time by approximately 4 hours per day This article was published in the following Dove Press journal: Clinical Ophthalmology 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 Srinivasan 3 TearScience Inc., Morrisville, NC, School of Optometry, The University of Alabama at Birmingham, AB, USA; 3 School 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 1 2 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,0.0001), SPEED (−8.4±4.7 vs −0.7±4.4, p,0.0001) and significantly greater improvement in exploratory variables (TBUT, LWE, and frequency of OTC drop use) relative to the controls. Mean comfortable contact lens wearing time increased by 4.0±3.9 hours at 1 month. This was sustained for 3 months with no change in the control group. The crossover treatment group demonstrated similar results to the treatment group at 1 month post-VTP. Conclusion: In SCL wearers with MGD, a single VTP treatment significantly improved mean meibomian gland function and significantly reduced dry eye signs and symptoms compared to an untreated control. The treatment increased mean comfortable lens wearing time by 4 hours (approximately doubling the pretreatment findings). This was sustained for up to 3 months post-treatment on average. Keywords: meibomian gland dysfunction, vectored thermal pulsation, Dynamic Meibomian Imaging, evaporative dry eye, soft contact lens wear, comfortable contact lens wearing time Introduction Correspondence: Caroline A Blackie TearScience Inc., 5151 McCrimmon Parkway, Suite 250, Morrisville, NC 27560, USA Tel +1 919 459 4880 Fax +1 919 467 3300 Email Symptoms of dryness and discomfort are highly prevalent (up to 50%) among contact lens wearers and are the most commonly cited reason for the discontinuation of contact lens wear.1–4 Despite decades of advances in contact lens design and materials used to manufacture the lenses, the contact lens dropout rate remains consistently high at 16%–34% per year.4,5 The improvements in contact lens design serve, in part, submit your manuscript | www.dovepress.com Clinical Ophthalmology 2018:12 169–183 Dovepress © 2018 Blackie et al. This work is published and licensed by Dove Medical Press Limited. 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Blackie et al to minimize the discomfort caused by the physical changes, which occur to a contact lens within minutes and hours of placement on the eye (eg, lens dehydration, pre-lens tear film stagnation, and post-lens debris).6–8 However, regardless of lens design optimization, there are ocular tissue changes that occur due to the disruptive presence of any contact lens on the eye.3,6–8 Examples of ocular tissue changes that have been reported as strongly correlated with contact lens wear are lid wiper epitheliopathy (LWE), lid parallel conjunctival folds (LIPCOF), and meibomian gland dysfunction (MGD).9–11 The mechanisms responsible for these tissue changes can be largely categorized as the result of increased evaporative stress on the tear film, friction between the lid wiper and the ocular surface, and the resulting inflammatory cascades that predictably ensue.12 Generally speaking, even with optimized contact lens design and materials, the importance of a stable and robust tear film and homeostatic ocular surface environment cannot be overstated, if successful contact lens wear is to be achieved.6,13,14 While the volume of literature regarding the need for tear film stability in order to achieve comfortable contact lens wear is significant, the full extent of the impact of a contact lens on the ocular surface is not fully understood or characterized. A recent publication hypothesizes the adverse effect of a contact lens on the eye through the mechanism of chronic desiccating stress.15 Chronic exposure to desiccating stress has been shown to result in protracted overstimulation of mouse meibomian gland meiboctyes. The unrelenting meibocyte upregulation accelerated the aging of the meibocytes, altered gland secretion quality, and ultimately led to gland atrophy in what were once healthy meibomian glands.15 While the direct link between MGD and chronic exposure to desiccating stress, alone or in contact lens wear, has not been demonstrated in the human eye, the reported association between contact lens wear and MGD, now spanning several decades, is well established.11,16,18–20 The multiple studies noting the high prevalence and increased severity of MGD in contac (...truncated)