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

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. Keywords: corneal staining, meibomian gland dysfunction, meibomian gland score, tear break-up time