Comparison of Two Thermal Pulsation Systems in the Treatment of Meibomian Gland Dysfunction: A Randomized, Multicenter Study

Abstract

SIGNIFICANCE: Given the significance of meibomian gland dysfunction subjects in evaporative dry eye, its chronic and progressive nature, limited promising treatment options, and novel treatment techniques are important. This randomized clinical study evaluated the noninferiority of SYSTANE iLux with LipiFlow in meibomian gland dysfunction treatment at 12 months. PURPOSE: This study aimed to demonstrate noninferiority of SYSTANE iLux compared with LipiFlow at 12 months after single treatment in meibomian gland dysfunction subjects with evaporative dry eye. METHODS: In this prospective, randomized, multicenter, assessor-masked, parallel-group trial, subjects (N = 236; aged ≥18 years) with meibomian gland score (MGS) of ≤12 in lower eyelids, noninvasive tear breakup time (NITBUT; first breakup) of <10 seconds, and Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score of >16 were randomized (1:1) to receive SYSTANE iLux (n = 119) or LipiFlow (n = 117). Subjects attended a total of eight visits, including screening, treatment, and follow-up visits at 2 weeks and at 1, 3, 6, 9, and 12 months/ exit, to evaluate change from baseline in MGS, NITBUT, IDEEL-SB module score, and safety outcomes.RESULTS: A total of 227 subjects completed the study (mean ± standard deviation age, 57.3 ± 13.8 years). At 12 months, least squares mean change from baseline in MGS was similar between iLux and LipiFlow (17.4 ± 1.97 vs. 17.8 ± 1.98). Noninferiority of SYSTANE iLux compared with LipiFlow in change from baseline in MGS (95% lower confidence limit of least squares mean difference, >−5), NITBUT (>−2.5 seconds), and IDEEL-SB score (95% upper confidence limit, <12) was achieved at all post-treatment visits. No other serious ocular or device-related adverse events were reported. CONCLUSIONS:The treatment outcomes with SYSTANE iLux were noninferior to LipiFlow during the 12-month follow-up in subjects with dry eye-associated meibomian gland dysfunction.

Systane iLux Thermal Pulsation System in the Treatment of Meibomian Gland Dysfunction: A Post-Hoc Analysis of a 12-Month, Randomized, Multicenter Study

“…The study details have been published in detail previously. 17 In the current post-hoc analysis, we report data on the Systane iLux treatment group from baseline to 12 months.…”

“…18 Two recent studies have compared Systane iLux and LipiFlow treatments in patients with MGD. 17,18 Both devices were reported to significantly improve MGD signs and symptoms, over 4 weeks of treatment. 18 Further, Systane iLux was reported to be non-inferior to LipiFlow in improving MGD scores, over 12 months.…”

“…14 Thermal pulsation therapies, such as LipiFlow and Systane iLux, have been reported to be highly efficient, with the effects lasting for up to 12 months. [15][16][17] The Systane iLux MGD treatment system (Alcon, Fort Worth, TX, USA) is a handheld, thermal pulsation device. 18 Two recent studies have compared Systane iLux and LipiFlow treatments in patients with MGD.…”

“…18 Further, Systane iLux was reported to be non-inferior to LipiFlow in improving MGD scores, over 12 months. 17 Although previous studies have evaluated Systane iLux, [17][18][19] comprehensive monadic data describing trends in outcomes associated with Systane iLux treatment over the long-term have not been reported so far. Here, we report post-hoc analysis of a previous randomized controlled trial (NCT03956225) to demonstrate the effectiveness of Systane iLux in patients with MGD over 12 months post single treatment.…”

“…post single treatment, in a 12-month randomized controlled trial. 17 The current post-hoc analysis of the previous randomized trial 17 was conducted to provide comprehensive monadic data on long-term Systane iLux effectiveness.…”