Status:

COMPLETED

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

Lead Sponsor:

Oslo University Hospital

Collaborating Sponsors:

Schepens Eye Research Institute

The Norwegian Dry Eye Clinic

Conditions:

Dry Eye Syndromes

Meibomian Gland Dysfunction

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 ...

Eligibility Criteria

Inclusion

  • 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

  • Glaucoma,
  • Ocular allergy
  • Autoimmune disease
  • Contact lens-wear during study
  • Current punctal plugging
  • Pregnant/lactating
  • Candidate for topical anti-inflammatory
  • Cicatricial meibomian gland dysfunction

Key Trial Info

Start Date :

October 19 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 17 2021

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT03318874

Start Date

October 19 2017

End Date

November 17 2021

Last Update

November 22 2021

Active Locations (1)

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The Norwegian Dry Eye Clinic

Oslo, Norway, 0369