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

November 19, 2021 updated by: Jonatan Olafsson, Oslo University Hospital

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).

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0369
        • The Norwegian Dry Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blephasteam
Heat delivery device, to be used according to guidelines from manufacturer.
Device: Blephasteam
Steam delivery goggles, once daily
Drug: Hylo-comod
Tear substitute containing hyaluronic acid, four times daily
Other Names:
  • Sodium hyaluronate
Active Comparator: THERA°PEARL Eye Mask
Heat delivery device, to be used according to guidelines from manufacturer.
Drug: Hylo-comod
Tear substitute containing hyaluronic acid, four times daily
Other Names:
  • Sodium hyaluronate
Device: THERA°PEARL Eye Mask
Heat delivery device, delivering heat to the eyelids, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear film break-up time
Time Frame: Change from baseline at three and six months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Surface Disease Index
Time Frame: Change from baseline at three and six months
Dry Eye Self reported Questionnaire, score ranging from 0-100, where lower values are considered preferable for the patients, indicating less symptoms. Values over 12 are indicative for dry eye disease.
Change from baseline at three and six months
McMonnies Questionnaire
Time Frame: Change from baseline at three and six months
Dry Eye Self reported Questionnaire. Index ranges from 0 to 45, where a higher score is regarded as more indicative of dry eye disease. A cut-point of greater than 14.5 is recommended for a dry eye diagnosis.
Change from baseline at three and six months
Ocular surface staining Ocular surface staining
Time Frame: Change from baseline at three and six months
Fluorescein applied to tear film, staining scored after the Oxford staining scheme, values ranging from 0-15, lower values are considered better for the patient.
Change from baseline at three and six months
Tear cytokine levels
Time Frame: Change from baseline at three and six months
Multiplex analysis of tear fluid
Change from baseline at three and six months
Schirmer's test
Time Frame: Change from baseline at three and six months
Measurement of 5 minutes of tear production, values ranging from 0 and higher, where lower values are considered worse for the patient. Values under 5 mm are indicative for dry eye disease.
Change from baseline at three and six months
Meibum Quality
Time Frame: Change from baseline at three and six months
Guidelines based on MGD-report of 2011, values ranging from 0-24, where lower values are considered better for the patient, indicating the quality of the meibum secretion.
Change from baseline at three and six months
Meibum Expressibility
Time Frame: Change from baseline at three and six months
Guidelines based on MGD-report of 2011, values ranging from 0-3, where lower values are considered better for the patient, indicating open meibomian glands.
Change from baseline at three and six months
Tear osmolarity
Time Frame: Change from baseline at three and six months
Osmolarity measured with TearLab, where values under 300 mOsml/L are considered normal.
Change from baseline at three and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Schepens Eye Research Institute
The Norwegian Dry Eye Clinic

Investigators

  • Principal Investigator: Tor P Uthiem, MD, Phd., Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2017

Primary Completion (Actual)

April 15, 2020

Study Completion (Actual)

November 17, 2021

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 18, 2017

First Posted (Actual)

October 24, 2017

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/1983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Syndromes

Clinical Trials on Blephasteam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe