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

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

doi:10.1038/s41598-021-01899-8

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

Sci Rep. 2021 Nov 17;11(1):22386. doi: 10.1038/s41598-021-01899-8.

Authors

Jonatan Olafsson^{1

2}, Xiaoran Lai³, Erlend Christoffer Sommer Landsend⁴, Snorri Olafsson^{5

6}, Eric Parissi⁷, Øygunn A Utheim^{8

9

10}, Sten Raeder^{8

10}, Reza A Badian^{9

10

11}, Neil Lagali^{12

13}, Darlene A Dartt¹⁴, Tor P Utheim^{9

10

4

11

13

15}

Affiliations

¹ Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Klaus Torgårds vei 3, 0372, Oslo, Norway. [email protected].
² Department of Medical Biochemistry, Oslo University Hospital, Nydalen, P.O. Box 4950, 0424, Oslo, Norway. [email protected].
³ Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Blindern, P.O. Box 1122, 0317, Oslo, Norway.
⁴ Department of Ophthalmology, Oslo University Hospital, Nydalen, P.O. Box 4950, 0424, Oslo, Norway.
⁵ Department of Gastroenterology, Innlandet Hospital Trust, Kyrre Grepps gate 11, 2816, Gjøvik, Norway.
⁶ Loma Linda University Medical Center, 11234 Anderson St., Loma Linda, CA, 92354, USA.
⁷ Lavista Optometry, Dampsagveien 4, 2000, Lillestrom, Norway.
⁸ Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Klaus Torgårds vei 3, 0372, Oslo, Norway.
⁹ Department of Medical Biochemistry, Oslo University Hospital, Nydalen, P.O. Box 4950, 0424, Oslo, Norway.
¹⁰ The Norwegian Dry Eye Clinic, Ole Vigs gate 32E, 0366, Oslo, Norway.
¹¹ Department of Optometry, Radiography and Lighting, National Centre for Optics, Vision and Eye Care, Faculty of Health and Social Sciences, University of Southeast Norway, P.O. Box 235, 3603, Kongsberg, Norway.
¹² Division of Ophthalmology, Department of Biomedical and Clinical Sciences, Linköping University, 581 83, Linköping, Sweden.
¹³ Department of Ophthalmology, Sørlandet Hospital Arendal, Sykehusveien 1, 4838, Arendal, Norway.
¹⁴ Department of Ophthalmology, Schepens Eye Research Institute/Massachusetts Eye and Ear, Harvard Medical School, 20 Staniford St., Boston, MA, 02114, USA.
¹⁵ Department of Ophthalmology, Stavanger University Hospital, P.O. Box 8100, 4068, Stavanger, Norway.

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.

Publication types

Clinical Trial
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Combined Modality Therapy
Female
Humans
Longitudinal Studies
Male
Meibomian Gland Dysfunction / therapy*
Physical Therapy Modalities*
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT03318874