NCT03318874

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

October 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2021

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

2.5 years

First QC Date

October 4, 2017

Last Update Submit

November 19, 2021

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Keywords

Dry Eye DiseaseMeibomian Gland DysfunctionBlephasteamTHERA°PEARL Eye Mask

Outcome Measures

Primary Outcomes (1)

  • Tear film break-up time

    Fluorescein applied to tear film, time measured until tear film breaks up after blink. Range of scale from 1 second and higher, where higher values are considered preferable for the patients. Values under 10 seconds are indicative for dry eye disease.

    Change from baseline at three and six months

Secondary Outcomes (8)

  • Ocular Surface Disease Index

    Change from baseline at three and six months

  • McMonnies Questionnaire

    Change from baseline at three and six months

  • Ocular surface staining Ocular surface staining

    Change from baseline at three and six months

  • Tear cytokine levels

    Change from baseline at three and six months

  • Schirmer's test

    Change from baseline at three and six months

  • +3 more secondary outcomes

Study Arms (2)

Blephasteam

EXPERIMENTAL

Heat delivery device, to be used according to guidelines from manufacturer.

Device: BlephasteamDrug: Hylo-comod

THERA°PEARL Eye Mask

ACTIVE COMPARATOR

Heat delivery device, to be used according to guidelines from manufacturer.

Device: THERA°PEARL Eye MaskDrug: Hylo-comod

Interventions

BlephasteamDEVICE

Steam delivery goggles, once daily

Blephasteam
THERA°PEARL Eye MaskDEVICE

Heat delivery device, delivering heat to the eyelids, once daily

THERA°PEARL Eye Mask
Hylo-comodDRUG

Tear substitute containing hyaluronic acid, four times daily

Also known as: Sodium hyaluronate
BlephasteamTHERA°PEARL Eye Mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Norwegian Dry Eye Clinic

Oslo, 0369, Norway

Location

Related Publications (1)

  • 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.

    PMID: 34789807DERIVED

MeSH Terms

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesEyelid Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Tor P Uthiem, MD, Phd.

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Student

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 24, 2017

Study Start

October 19, 2017

Primary Completion

April 15, 2020

Study Completion

November 17, 2021

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations

NO(1)