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, Maccles...

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Autores principales: Jonatan Olafsson, Xiaoran Lai, Erlend Christoffer Sommer Landsend, Snorri Olafsson, Eric Parissi, Øygunn A. Utheim, Sten Raeder, Reza A. Badian, Neil Lagali, Darlene A. Dartt, Tor P. Utheim
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Publicado: Nature Portfolio 2021
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spelling oai:doaj.org-article:899420784eb743f4964bd70d03d513ec2021-11-21T12:22:48ZTheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial10.1038/s41598-021-01899-82045-2322https://doaj.org/article/899420784eb743f4964bd70d03d513ec2021-11-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-01899-8https://doaj.org/toc/2045-2322Abstract 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.Jonatan OlafssonXiaoran LaiErlend Christoffer Sommer LandsendSnorri OlafssonEric ParissiØygunn A. UtheimSten RaederReza A. BadianNeil LagaliDarlene A. DarttTor P. UtheimNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-10 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Jonatan Olafsson
Xiaoran Lai
Erlend Christoffer Sommer Landsend
Snorri Olafsson
Eric Parissi
Øygunn A. Utheim
Sten Raeder
Reza A. Badian
Neil Lagali
Darlene A. Dartt
Tor P. Utheim
TheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial
description 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.
format article
author Jonatan Olafsson
Xiaoran Lai
Erlend Christoffer Sommer Landsend
Snorri Olafsson
Eric Parissi
Øygunn A. Utheim
Sten Raeder
Reza A. Badian
Neil Lagali
Darlene A. Dartt
Tor P. Utheim
author_facet Jonatan Olafsson
Xiaoran Lai
Erlend Christoffer Sommer Landsend
Snorri Olafsson
Eric Parissi
Øygunn A. Utheim
Sten Raeder
Reza A. Badian
Neil Lagali
Darlene A. Dartt
Tor P. Utheim
author_sort Jonatan Olafsson
title TheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial
title_short TheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial
title_full TheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial
title_fullStr TheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial
title_full_unstemmed TheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial
title_sort therapearl eye mask and blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/899420784eb743f4964bd70d03d513ec
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