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Randomized Controlled Trial
. 2022 Apr 1;99(4):323-332.
doi: 10.1097/OPX.0000000000001892.

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

Gina Wesley  1 , Katherine Bickle  2 , Johnathon Downing  3 , Bret Fisher  4 , Brennan Greene  5 , Colton Heinrich  6 , David Kading  7 , Shane Kannarr  8 , Jason Miller  9 , Satish Modi  10 , David Ludwick  11 , Joseph Tauber  12 , Sruthi Srinivasan, Venkiteshwar Manoj  13
Affiliations
Randomized Controlled Trial

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

Gina Wesley et al. Optom Vis Sci. .

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.

Trial registration: ClinicalTrials.gov NCT03956225.

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Conflict of interest statement

Conflict of Interest Disclosure: GW is a consultant for Alcon, Aerie, Allergan, Bausch, BioTissue, Coopervision, Johnson & Johnson, OcuSoft, Optovue, Orasis, and Tarsus Medical. CH is an educational consultant for Valley Contax. SM and BF are consultants for Alcon. JT was paid as a clinical investigator with a research grant from Alcon. DK was paid as a researcher for Alcon. KB, JD, BG, JM, DL, and SK have no financial interests to disclose. SS and VM are employees of Alcon. This research was funded by Alcon.

References

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