Dry Eye Syndromes, Meibomian Gland Dysfunction
Conditions
Keywords
Dry Eye Disease, Meibomian Gland Dysfunction, Blephasteam, THERA°PEARL Eye Mask
Brief summary
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).
Interventions
DEVICEBlephasteam
Steam delivery goggles, once daily
DEVICETHERA°PEARL Eye Mask
Heat delivery device, delivering heat to the eyelids, once daily
DRUGHylo-comod
Tear substitute containing hyaluronic acid, four times daily
Sponsors
Schepens Eye Research Institute
The Norwegian Dry Eye Clinic
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear film break-up time | 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
| Measure | Time frame | Description |
|---|---|---|
| McMonnies Questionnaire | 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. |
| Ocular surface staining Ocular surface staining | 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. |
| Tear cytokine levels | Change from baseline at three and six months | Multiplex analysis of tear fluid |
| Ocular Surface Disease Index | 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. |
| Meibum Quality | 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. |
| Meibum Expressibility | 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. |
| Tear osmolarity | Change from baseline at three and six months | Osmolarity measured with TearLab, where values under 300 mOsml/L are considered normal. |
| Schirmer's test | 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. |
Countries
Norway
Outcome results
None listed