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).
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Oct 2017 to primary completion in Apr 2020, 29 months.
Of 84 non-industry phase 4 interventional studies under Dry Eye Syndromes, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's 29 months is above that.
Counting every sponsor, half of 112 studies reached it within 12 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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