Durability of Treatment with a Thermomechanical Device in Meibomian Gland Dysfunction: An Observational Extension Study.

Abstract

Purpose: To evaluate the durability of thermomechanical device treatment effect in patients with meibomian gland dysfunction (MGD) at 6 months post-treatment. Methods: This was an extension of an initial 3-month, prospective, controlled, randomized, masked, multicenter pivotal study, in which subjects with MGD were randomized to thermomechanical device treatment (3 sessions, 2 weeks apart) or a single control treatment. The extension study was a single-arm, observational study in the same 5 sites of the pivotal study. A subset of subjects from the thermomechanical device group with an increase in tear break-up time (TBUT) of 2.5 s or greater in at least 1 eye at 1- or 3-month follow-up and able to attend the 6-month follow-up were included. Effectiveness endpoints included changes in TBUT, Meibomian gland score (MGS), and Ocular Surface Disease Index (OSDI) from baseline to 6 months. Device-related adverse events (AEs) were also assessed. Results: At 6 months post-treatment, 21 subjects (42 eyes) demonstrated significant improvements from baseline in mean TBUT (5.2 ± 3.8 s; P < 0.001), mean MGS (18.2 ± 10.9; P < 0.0001), and mean OSDI (-24.3 ± 26.5; P = 0.0004). Improvements in corneal staining scores were also observed. No ocular AEs were reported. Conclusions: The findings of the extension study demonstrate that the clinical benefit of the thermomechanical device, evaluated by TBUT, MGS, and OSDI, can be maintained out to 6 months and that the device is safe and effective in improving the signs and symptoms of evaporative dry eye disease in MGD.