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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1
The Norwegian Dry Eye Clinic
Oslo, Norway, 0369