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

Phase 4

Completed

• Conditions: Dry Eye Syndromes; Meibomian Gland Dysfunction
• Interventions: Device: Blephasteam; Device: THERA°PEARL Eye Mask; Drug: Hylo-comod

• Registration Number: NCT03318874
• Lead Sponsor: Oslo University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-18
• Study Start: 2017-10-19
• Study First Posted: 2017-10-24
• Primary Completion: 2020-04-15
• Status Verified: 2021-11
• Study Completion: 2021-11-17
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blephasteam	Blephasteam	Heat delivery device, to be used according to guidelines from manufacturer.
Blephasteam	Hylo-comod	Heat delivery device, to be used according to guidelines from manufacturer.
THERA°PEARL Eye Mask	THERA°PEARL Eye Mask	Heat delivery device, to be used according to guidelines from manufacturer.
THERA°PEARL Eye Mask	Hylo-comod	Heat delivery device, to be used according to guidelines from manufacturer.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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.
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.
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.
Tear cytokine levels	Change from baseline at three and six months	Multiplex analysis of tear fluid
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.

Trial Locations

Locations (1)

The Norwegian Dry Eye Clinic; 🇳🇴 Oslo, Norway