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

• Status: Active, not recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborators: Schepens Eye Research Institute; The Norwegian Dry Eye Clinic
• Treatments: Hyaluronic Acid

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

• Pregnant/lactating

• Candidate for topical anti-inflammatory

• Cicatricial meibomian gland dysfunction