Effectiveness and safety of a thermo-mechanical action device versus thermal pulsation device in the treatment of meibomian gland dysfunction.

PURPOSE

To evaluate the safety and effectiveness of thermo-mechanical action (Tixel C, Novoxel) compared with thermal pulsation (LipiFlow, Johnson & Johnson) in meibomian gland dysfunction (MGD).

SETTING

Private clinics and University clinic, USA.

DESIGN

Prospective, randomized (1:1), evaluator-masked, multicenter study.

METHODS

Subjects with Ocular Surface Disease Index (OSDI) between 23 and 79, fluorescein tear break-up time (TBUT) <10 s and Meibomian Gland Score (MGS) ≤12 in each eye received bilateral thermo-mechanical action (TMA) or thermal pulsation (TP). The treatment consisted of three sessions, two weeks apart, for TMA and one session for TP. TBUT, OSDI, MGS, and corneal and conjunctival staining (CCS) were assessed at baseline and at Weeks 4 and 12 post-last treatment session. The primary effectiveness endpoint was change in TBUT at Week 4.

RESULTS

Among the 106 treated subjects (N=53 per group), TBUT improved significantly (p<0.001) by 3.0±3.2 and 3.1±4.3 seconds after TMA and 2.7±2.7 and 3.3±3.6 seconds after TP, at Week 4 and Week 12, respectively. The change in TBUT for TMA was non-inferior to TP (linear mixed-effects model, p<0.001). OSDI, MGS and CCS significantly improved from baseline (p<0.001), with no significant between-group differences (p>0.05). OSDI improved by 26.4±21.1 and 28.6±22.4 after TMA and 18.8±21.0 and 21.9±18.5 after TP, at Week 4 and Week 12, respectively. No device-related adverse event occurred in either group.

CONCLUSION

TMA safely and effectively improved clinical signs and symptoms of evaporative dry eye disease associated with MGD over a 12-week period, comparable to TP.