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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Steam delivery goggles, once daily
Heat delivery device, delivering heat to the eyelids, once daily
Tear substitute containing hyaluronic acid, four times daily
The Norwegian Dry Eye Clinic
Oslo, Norway
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
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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