A Phase 4 interventional study of Blephasteam and THERA°PEARL Eye Mask in Dry Eye Syndromes and Meibomian Gland Dysfunction, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-22.
Sponsored by Oslo University Hospital · Phase 4, Interventional, and Treatment
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).
Exclusion Criteria:
Heat delivery device, to be used according to guidelines from manufacturer.
Device: Blephasteam · Drug: Hylo-comod
Heat delivery device, to be used according to guidelines from manufacturer.
Device: THERA°PEARL Eye Mask · Drug: Hylo-comod
Steam delivery goggles, once daily
Heat delivery device, delivering heat to the eyelids, once daily
Tear substitute containing hyaluronic acid, four times daily
Also known as: Sodium hyaluronate
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.
Time frame: Change from baseline at three and six months
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.
Time frame: Change from baseline at three and six months
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.
Time frame: Change from baseline at three and six months
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.
Time frame: Change from baseline at three and six months
Tear cytokine levels
Multiplex analysis of tear fluid
Time frame: Change from baseline at three and six months
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.
Time frame: Change from baseline at three and six months
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.
Time frame: Change from baseline at three and six months
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.
Time frame: Change from baseline at three and six months
Tear osmolarity
Osmolarity measured with TearLab, where values under 300 mOsml/L are considered normal.
Time frame: Change from baseline at three and six months
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Oslo University Hospital