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

Sponsor
Oslo University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03318874
Collaborator
Schepens Eye Research Institute (Other), The Norwegian Dry Eye Clinic (Other)
70
Enrollment
1
Location
2
Arms
49
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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).
Actual Study Start Date :
Oct 19, 2017
Actual Primary Completion Date :
Apr 15, 2020
Actual Study Completion Date :
Nov 17, 2021

Arms and Interventions

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.

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tear film break-up time [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.

    Secondary Outcome Measures

    1. Ocular Surface Disease Index [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.

    2. McMonnies Questionnaire [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.

    3. Ocular surface staining Ocular surface staining [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.

    4. Tear cytokine levels [Change from baseline at three and six months]

      Multiplex analysis of tear fluid

    5. Schirmer's test [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.

    6. Meibum Quality [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.

    7. Meibum Expressibility [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.

    8. Tear osmolarity [Change from baseline at three and six months]

      Osmolarity measured with TearLab, where values under 300 mOsml/L are considered normal.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Norwegian Dry Eye Clinic Oslo Norway 0369

    Sponsors and Collaborators

    • Oslo University Hospital
    • Schepens Eye Research Institute
    • The Norwegian Dry Eye Clinic

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonatan Olafsson, Medical Student, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT03318874
    Other Study ID Numbers:
    • 2014/1983
    First Posted:
    Oct 24, 2017
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by Jonatan Olafsson, Medical Student, Oslo University Hospital
    Dry Eye Disease
    Meibomian Gland Dysfunction
    Blephasteam
    THERA°PEARL Eye Mask
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Meibomian Gland Dysfunction
    Hyaluronic Acid

    Study Results

    No Results Posted as of Nov 22, 2021