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

NCT03318874 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-11-22

No results posted yet for this study

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).

Conditions

  • Dry Eye Syndromes
  • Meibomian Gland Dysfunction

Interventions

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

Sponsors & Collaborators

  • Schepens Eye Research Institute

    collaborator OTHER

  • The Norwegian Dry Eye Clinic

    collaborator OTHER_GOV

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Tor P Uthiem, MD, Phd. · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-19
Primary Completion
2020-04-15
Completion
2021-11-17

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03318874 on ClinicalTrials.gov