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

Study Overview
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Brief Summary
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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).

Official Title
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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).

Conditions
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Dry Eye Syndromes, Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: Blephasteam
* Device: THERA°PEARL Eye Mask
* Drug: Hylo-comod


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blephasteam<br>Heat delivery device, to be used according to guidelines from manufacturer. | Device: Blephasteam<br>* Steam delivery goggles, once daily<br>Drug: Hylo-comod<br>* Tear substitute containing hyaluronic acid, four times daily<br>* Other names: Sodium hyaluronate;|
| Active Comparator: THERA°PEARL Eye Mask<br>Heat delivery device, to be used according to guidelines from manufacturer. | Device: THERA°PEARL Eye Mask<br>* Heat delivery device, delivering heat to the eyelids, once daily<br>Drug: Hylo-comod<br>* Tear substitute containing hyaluronic acid, four times daily<br>* Other names: Sodium hyaluronate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline at three and six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Change from baseline at three and six months | 
| Tear cytokine levels | Multiplex analysis of tear fluid | 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. | 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. | 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. | Change from baseline at three and six months | 
| Tear osmolarity | Osmolarity measured with TearLab, where values under 300 mOsml/L are considered normal. | Change from baseline at three and six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Disease, Meibomian Gland Dysfunction, Blephasteam, THERA°PEARL Eye Mask