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NCT Number: NCT03318874

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

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).

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Norwegian Dry Eye Clinic

Oslo, 0369, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blephasteam

Device

Steam delivery goggles, once daily

THERA°PEARL Eye Mask

Device

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

Hylo-comod

Drug

Tear substitute containing hyaluronic acid, four times daily

Other names: Sodium hyaluronate

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Tear cytokine levels

    Time frame: Change from baseline at three and six months

    Multiplex analysis of tear fluid

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Schepens Eye Research Institute
  • The Norwegian Dry Eye Clinic

Registry information

Official study 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).

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Oct 24, 2017
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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