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

Dry Eye Syndromes Clinical Trial

Official title:

Comparing the Effects of THERA°PEARL Eye Mask (Bausch & Lomb Inc., New York, USA) With the Use of Blephasteam® (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03318874
• Other study ID #: 2014/1983
• Status: Completed
• Phase: Phase 4
• Start date: October 19, 2017
• Est. completion date: November 17, 2021

Study information

• Verified date: November 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 17, 2021
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

Device:
• Blephasteam
Steam delivery goggles, once daily
• THERA°PEARL Eye Mask
Heat delivery device, delivering heat to the eyelids, once daily

Drug:
• Hylo-comod
Tear substitute containing hyaluronic acid, four times daily

Locations

Country	Name	City	State
Norway	The Norwegian Dry Eye Clinic	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Schepens Eye Research Institute, The Norwegian Dry Eye Clinic

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear film break-up time	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.	Change from baseline at three and six months
Secondary	Ocular Surface Disease Index	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.	Change from baseline at three and six months
Secondary	McMonnies Questionnaire	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.	Change from baseline at three and six months
Secondary	Ocular surface staining Ocular surface staining	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.	Change from baseline at three and six months
Secondary	Tear cytokine levels	Multiplex analysis of tear fluid	Change from baseline at three and six months
Secondary	Schirmer's test	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.	Change from baseline at three and six months
Secondary	Meibum Quality	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.	Change from baseline at three and six months
Secondary	Meibum Expressibility	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.	Change from baseline at three and six months
Secondary	Tear osmolarity	Osmolarity measured with TearLab, where values under 300 mOsml/L are considered normal.	Change from baseline at three and six months