Optimization of the Treatment of Dry Eye Disease Caused by Meibomian Gland Dysfunction
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Blephasteam Heat delivery device, to be used according to guidelines from manufacturer. |
Device: Blephasteam
Steam delivery goggles, once daily
Drug: Hylo-comod
Tear substitute containing hyaluronic acid, four times daily
Other Names:
|
Active Comparator: THERA°PEARL Eye Mask Heat delivery device, to be used according to guidelines from manufacturer. |
Device: THERA°PEARL Eye Mask
Heat delivery device, delivering heat to the eyelids, once daily
Drug: Hylo-comod
Tear substitute containing hyaluronic acid, four times daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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
- 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.
- 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.
Eligibility Criteria
Criteria
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
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Pregnant/lactating
-
Candidate for topical anti-inflammatory
-
Cicatricial meibomian gland dysfunction
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The Norwegian Dry Eye Clinic | Oslo | Norway | 0369 |
Sponsors and Collaborators
- Oslo University Hospital
- Schepens Eye Research Institute
- The Norwegian Dry Eye Clinic
Investigators
- Principal Investigator: Tor P Uthiem, MD, Phd., Oslo University Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- 2014/1983