A Randomised Pilot Trial to Demonstrate the Feasibility of a Prototype Electronic Heating Device in Patients with...

Objectives: To compare the safety and efficacy of a prototype electronic heating device, Meiboleyes^®, with the BRUDER Moist Heat Eye Compress for the treatment of Meibomian Gland Dysfunction (MGD). Methods: Adults with evidence of active MGD (Ocular Surface Disease Index [OSDI] score ≥ 13, fluorescein tear break-up time [TBUT] < 10 s and meibomian gland secretion score ≤ 12 for 15 glands of the lower lid) were enrolled in this prospective, randomised, parallel group, investigator-masked dispensing study (Australian New Zealand Clinical Trials Registry-ACTRN12624000175572). Meibomian gland secretion (MGS) score and number of meibomian glands yielding liquid secretion (MGYLS), lipid layer thickness, TBUT, ocular physiology and subjective symptoms were measured at baseline, and 2 weeks and 6 weeks following treatment. Linear mixed model analysis was conducted to compare the two groups and changes over time. Results: Ten participants (average age 38.7 ± 14.5 years) in the Meiboleyes^® test group, and 10 participants (average age 38.9 ± 14.8 years) in the BRUDER control group completed the study. MGS and MGYLS significantly improved in both treatment groups from baseline to the 2-week and 6-week follow-up visits (p ≤ 0.006). Significant improvements in TBUT (5.5 ± 1.8 vs. 8.3 ± 2.1 s, p = 0.044), OSDI scores (45.2 ± 15.1 vs. 27.4 ± 12.9, p = 0.027) and visual analogue scale dryness (55.3 ± 27.2 vs. 28.0 ± 23.9, p = 0.023) were observed in the Meiboleyes^® group only after 6 weeks of treatment. No other significant differences were observed over time or between groups. Eight treatment-related adverse events were reported in the Meiboleyes^® group compared to seven in the BRUDER group. All resolved without sequalae. Conclusions: The prototype Meiboleyes^® device was safe and effective for use as an at-home treatment for MGD when used twice daily for six weeks. Improvements in meibomian gland function were comparable to the BRUDER Moist Heat Eye Compress, but significant improvements in tear film stability and subjective comfort after 6 weeks of treatment were observed in the Meiboleyes^® group only.