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

University of Oslo (UIO)

Status and phase: Completed; Phase 4

Conditions: Meibomian Gland Dysfunction; Dry Eye Syndromes

Treatments: Device: THERA°PEARL Eye Mask; Drug: Hylo-comod; Device: Blephasteam

Study type: Interventional

Funder types: Other

Identifiers

NCT03318874

2014/1983

Details and patient eligibility

About

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).

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Blephasteam

Experimental group

Description:

Heat delivery device, to be used according to guidelines from manufacturer.

Treatment:

Drug: Hylo-comod

Device: Blephasteam

THERA°PEARL Eye Mask

Active Comparator group

Description:

Heat delivery device, to be used according to guidelines from manufacturer.

Treatment:

Device: THERA°PEARL Eye Mask

Drug: Hylo-comod