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

Primary Purpose

Dry Eye Syndromes, Meibomian Gland Dysfunction

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Blephasteam
THERA°PEARL Eye Mask
Hylo-comod
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Dry Eye Disease, Meibomian Gland Dysfunction, Blephasteam, THERA°PEARL Eye Mask

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Norwegian Dry Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blephasteam

THERA°PEARL Eye Mask

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Ocular Surface Disease Index
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.
McMonnies Questionnaire
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.
Ocular surface staining Ocular surface staining
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.
Tear cytokine levels
Multiplex analysis of tear fluid
Schirmer's test
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.
Meibum Quality
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.
Meibum Expressibility
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.
Tear osmolarity
Osmolarity measured with TearLab, where values under 300 mOsml/L are considered normal.

Full Information

First Posted
October 4, 2017
Last Updated
November 19, 2021
Sponsor
Oslo University Hospital
Collaborators
Schepens Eye Research Institute, The Norwegian Dry Eye Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03318874
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 19, 2017 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
November 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Schepens Eye Research Institute, The Norwegian Dry Eye Clinic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Meibomian Gland Dysfunction
Keywords
Dry Eye Disease, Meibomian Gland Dysfunction, Blephasteam, THERA°PEARL Eye Mask

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blephasteam
Arm Type
Experimental
Arm Description
Heat delivery device, to be used according to guidelines from manufacturer.
Arm Title
THERA°PEARL Eye Mask
Arm Type
Active Comparator
Arm Description
Heat delivery device, to be used according to guidelines from manufacturer.
Intervention Type
Device
Intervention Name(s)
Blephasteam
Intervention Description
Steam delivery goggles, once daily
Intervention Type
Device
Intervention Name(s)
THERA°PEARL Eye Mask
Intervention Description
Heat delivery device, delivering heat to the eyelids, once daily
Intervention Type
Drug
Intervention Name(s)
Hylo-comod
Other Intervention Name(s)
Sodium hyaluronate
Intervention Description
Tear substitute containing hyaluronic acid, four times daily
Primary Outcome Measure Information:
Title
Tear film break-up time
Description
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.
Time Frame
Change from baseline at three and six months
Secondary Outcome Measure Information:
Title
Ocular Surface Disease Index
Description
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.
Time Frame
Change from baseline at three and six months
Title
McMonnies Questionnaire
Description
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.
Time Frame
Change from baseline at three and six months
Title
Ocular surface staining Ocular surface staining
Description
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.
Time Frame
Change from baseline at three and six months
Title
Tear cytokine levels
Description
Multiplex analysis of tear fluid
Time Frame
Change from baseline at three and six months
Title
Schirmer's test
Description
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.
Time Frame
Change from baseline at three and six months
Title
Meibum Quality
Description
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.
Time Frame
Change from baseline at three and six months
Title
Meibum Expressibility
Description
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.
Time Frame
Change from baseline at three and six months
Title
Tear osmolarity
Description
Osmolarity measured with TearLab, where values under 300 mOsml/L are considered normal.
Time Frame
Change from baseline at three and six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tor P Uthiem, MD, Phd.
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Norwegian Dry Eye Clinic
City
Oslo
ZIP/Postal Code
0369
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34789807
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.
Results Reference
derived

Learn more about this trial

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

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