Systane iLux Thermal Pulsation System in the Treatment of Meibomian Gland Dysfunction: A Post-Hoc Analysis of a 12-Month, Randomized, Multicenter Study
Gina Wesley, Katherine Bickle, Johnathon Downing, Bret Fisher, Brennan Greene, Colton Heinrich, David Kading, Shane Kannarr, Jason Miller, Satish Modi, David Ludwick, Joseph Tauber, Thao N. Yeh, Sruthi Srinivasan
Abstract
Purpose: This study aimed to demonstrate the effectiveness of Systane iLux, a thermal pulsation device, in patients with MGD, over 12 months post-single treatment. Methods: This is a post-hoc analysis of a previous prospective, assessor-masked, parallel-group, multicenter study (NCT03956225) that compared the effectiveness and safety of iLux with LipiFlow in subjects with MGD. The original study included subjects with meibomian gland score (MGS) ≤12 in lower eyelids, Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score >16, and non-invasive tear break-up time (NITBUT) <10 seconds. Subjects were randomized (1:1) to receive a single bilateral treatment of iLux or LipiFlow. In this post-hoc analysis, mean changes in MGS, NITBUT (first break-up; seconds), IDEEL-SB module score, and corneal staining, from baseline to 12 months were analyzed post-single treatment with iLux. Results: Data from 119 patients (n=238 eyes) treated with iLux were analyzed. The mean±SD age of the subjects was 58.4±13.4 years, with majority being female (79.0%). MGS (mean±SD) for both eyes improved significantly from baseline to 12 months (OD [baseline: 6.9±3.69; month 12: 22.8±11.31; change: 15.9±11.57, p<0.0001]; OS [baseline: 6.4±3.66; month 12: 23.0±11.33; change: 16.7±11.40, p<0.0001]). Similarly, significant improvements were observed in NITBUT (OD [baseline: 5.2±1.97; month 12: 7.0±3.68; change: 1.9±3.69, p<0.0001]; OS [baseline: 5.6±1.96; month 12: 7.9±4.58; change: 2.3±4.59, p<0.0001]) and IDEEL-SB score (p<0.0001). Corneal staining reduced significantly from baseline to 12 months (OD [baseline: 2.1±2.96; month 12: 0.7±1.56; change: -1.4±2.65, p<0.0001]; OS [baseline: 2.1±2.94; month 12: 0.7±1.44; change: -1.4±2.75, p<0.0001]). Improvements in MGS, NITBUT, IDEEL-SB module score, and corneal staining were seen as early as week 2, and at months 1, 3, 6, and 9 (all p<0.001). Conclusion: A single treatment with iLux significantly improved clinical parameters of MGS, NITBUT, and corneal staining, and patient-reported symptom assessment with IDEEL-SB in patients with MGD over 12 months.