Clinical trial NCT03318874: Optimization of the Treatment of Dry Eye Disease Caused by Meibomian Gland Dysfunction
Official title: Comparing the Effects of THERA°PEARL Eye Mask (Bausch & Lomb Inc., New York, USA) With the Use of Blephasteam® (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Meibomian Gland Dysfunction
Keywords: Dry Eye Disease
Meibomian Gland Dysfunction
Blephasteam
THERA°PEARL Eye Mask
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Schepens Eye Research Institute
name: The Norwegian Dry Eye Clinic
First posted: 2017-10-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open label, randomized controlled study in a Norwegian population with meibomian gland dysfunction. Patients will be randomized to one of two groups: THERA°PEARL Eye Mask (Bausch \& Lomb Inc., New York, USA) or Blephasteam® (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK). All patients will receive Hylo-comod (URSAPHARM Arzneimittel GmbH, Saarbrücken, Germany).


Eligibility criteria: Inclusion Criteria:

* Meibomian Gland Dysfunction
* Eligible for heat treatment
* Ocular Surface Disease Index (OSDI) \>12
* Quality or expressibility score ≤20 years old: \>1 or \>20 years old: ≥1
* Non-invasive tear film break-up time (NITBUT) \<10 s in at least one eye
* Schirmer-1 test \>5 mm after 5 min

Exclusion Criteria:

* Glaucoma,
* Ocular allergy
* Autoimmune disease
* Contact lens-wear during study
* Current punctal plugging
* Pregnant/lactating
* Candidate for topical anti-inflammatory
* Cicatricial meibomian gland dysfunction

Primary outcomes:
measure: Tear film break-up time
timeFrame: Change from baseline at three and six months
Secondary outcomes:
measure: Ocular Surface Disease Index
timeFrame: Change from baseline at three and six months
measure: McMonnies Questionnaire
timeFrame: Change from baseline at three and six months
measure: Ocular surface staining Ocular surface staining
timeFrame: Change from baseline at three and six months
measure: Tear cytokine levels
timeFrame: Change from baseline at three and six months
measure: Schirmer's test
timeFrame: Change from baseline at three and six months
measure: Meibum Quality
timeFrame: Change from baseline at three and six months
measure: Meibum Expressibility
timeFrame: Change from baseline at three and six months
measure: Tear osmolarity
timeFrame: Change from baseline at three and six months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: The Norwegian Dry Eye Clinic
Study officials:
affiliation: Oslo University Hospital
name: Tor P Uthiem, MD, Phd.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olafsson J, Lai X, Landsend ECS, Olafsson S, Parissi E, Utheim OA, Raeder S, Badian RA, Lagali N, Dartt DA, Utheim TP. 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.