Patient-reported symptoms following SYSTANE iLux and LipiFlow treatment: A 12-month, multicenter study

Abstract

Purpose : To demonstrate non-inferiority of iLux when compared to LipiFlow in change from baseline in the Impact of Dry Eye on Everyday Life (IDEEL) questionnaire Symptom Bother (SB) module score at 12 months post-single treatment in Meibomian gland dysfunction (MGD) subjects with evaporative dry eye (EDE).

Methods : This was a prospective, randomized, assessor-masked, parallel-group study comparing iLux to LipiFlow in subjects with EDE. Subjects with IDEEL-SB module scores of >16, non-invasive tear break-up time scores of <10 seconds, and Meibomian gland score ≤12 in lower eyelids were randomized for bilateral treatment in a 1:1 ratio to receive a single treatment with either SYSTANE iLux or LipiFlow. Subjects attended a total of 8 visits: Screening/Baseline, Treatment, 2-Week, 1-Month, 3-Month, 6-Month, 9-Month and 12-Month /Exit. At each time point, a paper copy of the IDEEL-SB module was provided to each patient for completion without assistance. Non-inferiority in IDEEL-SB module scores (change from baseline) between iLux compared to LipiFlow was assessed at all time points.

Results : A total of 227 treated (iLux 114; LipiFlow 113) patients completed the 12-month follow-up. Treatment difference (iLux minus LipiFlow) and the corresponding one-sided 95% upper confidence limit (UCL) were computed. Non-inferiority was declared if the UCL was less than 12. Non-inferiority of iLux compared to LipiFlow in change from baseline in IDEEL-SB scores was achieved at 2 weeks (2.56), 1 month (3.00), 3 months (2.21), 6 months (2.23), 9 months (1.92), and 12 months (2.42).

Conclusions : This study demonstrated that SYSTANE iLux MGD Thermal Pulsation System is non-inferior to LipiFlow Thermal Pulsation System in the change in IDEEL-SB scores up to 12 months following a single treatment.

This is a 2021 ARVO Annual Meeting abstract.