Trial | NCT03318874  Report issue

Title

Optimization of the Treatment of Dry Eye Disease Caused by Meibomian Gland Dysfunction
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).

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Hylo-comod ...

  • Study Participants

    70
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).
Study Started
Oct 19
2017
Primary Completion
Apr 15
2020
Study Completion
Nov 17
2021
Last Update
Nov 22
2021

Device Blephasteam

Steam delivery goggles, once daily

Device THERA°PEARL Eye Mask

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

Drug Hylo-comod

Tear substitute containing hyaluronic acid, four times daily

  • Other names: Sodium hyaluronate

Blephasteam Experimental

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

THERA°PEARL Eye Mask Active Comparator

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

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
No Results Posted