Thermo-Mechanical Action (TMA®) with Tixel for Evaporative Dry Eye Associated with Meibomian Gland Dysfunction: A Multicenter, Open-Label, Single-Arm, Exploratory Clinical Study

Background: Tixel® (Novoxel Ltd., Netanya, Israel) is a thermomechanical system that conducts heat to soft tissue via a titanium tip heated to 400 °C and has been used for skin rejuvenation, including the eyelids. Its efficacy for dry eye disease (DED) and meibomian gland dysfunction (MGD) has been reported, but it has not been evaluated in Japanese patients. Methods: This multicenter, open-label, single-arm, exploratory clinical study examined the efficacy and safety of Tixel for evaporative dry eye associated with MGD. Patients underwent three treatment sessions at 2-week intervals, with 10 pulses applied to the upper and lower eyelids of both eyes in two overlapping rows (skin contact, 6 ms; tip protrusion, 400 µm). The primary endpoint was the change in tear film break-up time (TBUT) and the secondary endpoint was the change in the Ocular Surface Disease Index (OSDI). Results: Twenty patients (4 men, 16 women; mean age, 53.6 ± 16.7 years) were enrolled, and 3 patients discontinued the study. The mean TBUT change was 2.470 s and OSDI improved by a mean of −29.459 (p < 0.0001). No major adverse events occurred. Conclusions: Tixel was associated with improved tear film stability and subjective symptoms, and no major adverse events were observed during the short follow-up period.