TheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial

Abstract

Meibomian gland dysfunction (MGD) is the most common cause of dry eye disease (DED). In this study, we aimed to compare the effects of eyelid warming treatment using either TheraPearl Eye Mask (Bausch & Lomb Inc., New York, USA) or Blephasteam (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK) in a Norwegian population with mild to moderate MGD-related DED. An open label, randomized comparative trial with seventy patients (49 females, 21 males; mean age 53.6 years). Patients were randomly assigned to treatment with Blephasteam (n = 37) or TheraPearl (n = 33). All received a hyaluronic acid based artificial tear substitute (Hylo-Comod, Ursapharm, Saarbrücken, Germany). Patients were examined at baseline, and at three and six months initiation of treatment. Treatment efficacy was primarily evaluated by fluorescein breakup time (FBUT) and Ocular Surface Disease Index (OSDI) scores. Other outcome measures included ocular surface staining (OSS), Schirmer's test, and meibomian quality and expressibility. Baseline parameter values did not differ between the groups. After six months of treatment, Blephasteam improved FBUT by 3.9 s (p < 0.01) and OSDI by 13.7 (p < 0.01), TheraPearl improved FBUT by 2.6 s (p < 0.01) and OSDI by 12.6 (p < 0.01). No difference between treatments was detected at 6 months (p = 0.11 for FBUT and p = 0.71 for OSDI), nor were there differences in the other tested parameters between the treatment groups. Blephasteam and TheraPearl are equally effective in treating mild to moderate MGD in a Norwegian population after 6-months of treatment.Clinicaltrials.gov ID: NCT03318874; Protocol ID: 2014/1983; First registration: 24/10/2017.

Conflict of interest statement

Snorri Olafsson is on the speaker bureau for Takeda Pharmaceuticals. Tor Paaske Utheim is co-founder and co-owner of The Norwegian dry eye clinic, which delivers talks for and/or receives financial support from the following: ABIGO, Alcon, Allergan, AMWO, Bausch&Lomb, European school for advanced studies in ophthalmology, InnZ Medical, Medilens Nordic, Medistim, Novartis, Santen, Specsavers, Shire and Thea Laboratoires. He has served on the global scientific advisory board for Novartis and Alcon as well as the European advisory board for Shire. Utheim is the Norwegian Global Ambassador for Tear Film and Ocular Surface Society (TFOS) and a board member of the International Ocular Surface Society. Sten Raeder has financial disclosers for Abigo, Alcon, AMWO, Bausch & Lomb, Medilens, Medistim, Novartis, Santen, Théa. In addition, he has co-founded the Norwegian Dry Eye Clinic. Darlene Dartt is a consultant for Coopervision. Jonatan Olafsson, Xiaoran Lai, Erlend Christoffer Sommer Landsend, Eric Parissi, Reza A. Badian, and Neil Lagali have no competing interests.

© 2021. The Author(s).

Figures

Figure 1

Blephasteam (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK) warms the eyelids by turning water in cotton rings into steam while placed over the eyes for 10 min. Figure created in Affinity Designer version 1.8 (Serif (Europe) Ltd., Nottingham, UK).

Figure 2

TheraPearl eye mask (Bausch & Lomb Inc., New York, USA) is preheated in a microwave before being placed on the eyelids for about 10–15 min. Figure created in Affinity Designer version 1.8 (Serif (Europe) Ltd., Nottingham, UK).

Figure 3

Patient inclusion, treatment allocation, and dropout. Figure created in PowerPoint version 16.53 (Microsoft, Washington, USA).

Figure 4

Compliance calculated as the average number of days per week that the patients were using the treatment. Smoothed conditional mean compliance were fitted using loess method for each treatment. 95% confidence bands were shown as shaded ribbon in respective colors. Figure created in R version 4.0 with ggplot2 package, version 3.3.5 (The R Foundation for Statistical Computing, Welthandelsplatz 1, 1020 Vienna, Austria).