Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000175572
Ethics application status
Approved
Date submitted
23/01/2024
Date registered
23/02/2024
Date last updated
12/08/2024
Date data sharing statement initially provided
23/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Meiboleyes® and BRUDER Moist Heat Eye Compress for the treatment of Meibomian Gland Dysfunction
Scientific title
Prospective, randomised, parallel group, bilateral treatment trial to demonstrate the feasibility of the Meiboleyes prototype electronic heating device when compared to the BRUDER Moist heat Eye Compress in patients with meibomian gland dysfunction.
Secondary ID [1] 310919 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye disease 331980 0
Meibomian Gland Dysfunction 332829 0
Condition category
Condition code
Eye 328719 328719 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a prospective, bilateral, randomised, parallel clinical trial. Participants will be assigned to use either the test device (Meiboleyes) or the control device (BRUDER).
Each participant will attend 3 visits of approximately 60min duration each, comprising of visit 1 (baseline/screening), visit 2 (2 weeks from baseline) and visit 3 (6 weeks from baseline). Their allocated study product will be dispensed at visit 1 and used for the duration of the study.
All visits are carried out by an optometrist and will comprise standard optometric assessments including visual acuity, subjective refraction (visit 1 only), slit lamp biomicroscopy for general ocular assessment as well as assessment of the meibomian glands and tear film. Questionnaires will also be administered.
Participants will be instructed to use their allocated study product twice per day, for 10-15 minutes each time. Both study products are heated then worn over the closed eyes, with the products fastened around the head with an elasticised strap. Meiboleyes is battery charged and heated through the press of a button and BRUDER is heated in the microwave. A diary will be deployed to collect product usage and assess compliance with the wear regime.
Intervention code [1] 327348 0
Treatment: Devices
Comparator / control treatment
The control will be a commercially available heating eye mask. The mask will be heated in the microwave then worn over the closed eyelids and fastened around the head with an elasticised strap. Both control and test products are worn around the eyes and both are used for the same duration.
Control group
Active

Outcomes
Primary outcome [1] 336525 0
Change in meibomian gland secretions, quality and number of glands yielding liquid secretions.
(Note: This is a composite outcome)
Timepoint [1] 336525 0
Visit 2 - approximately 2 weeks after visit 1
Visit 3 - approximately 6 weeks after visit 1
Primary outcome [2] 336526 0
Change in tear break up time
Timepoint [2] 336526 0
Visit 2 - approximately 2 weeks after visit 1
Visit 3 - approximately 6 weeks after visit 1
Primary outcome [3] 336527 0
Change in ocular physiology (corneal and conjunctival staining)
(Note: This is a composite outcome)
Timepoint [3] 336527 0
Visit 2 - approximately 2 weeks after visit 1
Visit 3 - approximately 6 weeks after visit 1
Secondary outcome [1] 428692 0
Change in subjective dry eye-related symptoms (comfort, dryness and vision)
(Note: This is a composite outcome)
Timepoint [1] 428692 0
Visit 2 - approximately 2 weeks after visit 1
Visit 3 - approximately 6 weeks after visit 1
Secondary outcome [2] 428693 0
Change in vision
Timepoint [2] 428693 0
Visit 2 - approximately 2 weeks after visit 1
Visit 3 - approximately 6 weeks after visit 1
Secondary outcome [3] 428694 0
Change in lipid layer thickness
Timepoint [3] 428694 0
Visit 2 - approximately 2 weeks after visit 1
Visit 3 - approximately 6 weeks after visit 1

Eligibility
Key inclusion criteria
• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
• Be at least 18 years old.
• Willing to comply with the clinical trial as directed by the Investigator.
• Best-corrected visual acuity of 20/40 or better in each eye at the baseline visit
• Evidence of meibomian gland obstruction (based on a meibomian gland secretion score of less than or equal to 12 for 15 glands of the lower lid) in both eyes at the baseline visit.
• Evidence of active MGD associated signs and symptoms at the baseline visit:
o OSDI questionnaire score more than or equal to 13
o Fluorescein TBUT < 10 seconds in both eyes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis sicca associated with MGD) or uncontrolled systemic disease;
• Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or corneal integrity;
• Ocular hypertension or diagnosed glaucoma;
• Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye at any time or anticipate such a procedure during the study;
• LipiFlow® or other professional in-office lid-heating therapy, meibomian gland probing, or therapeutic gland expression in either eye within 6 months prior to baseline;
• MGD treatments including warm compress therapy, eyelid hygiene, eyelid massage, and manual lid expression within 2 weeks prior to baseline;
• Corneal, conjunctival, or eyelid inflammation (including allergic, vernal, or giant papillary conjunctivitis and mucous membrane pemphigoid) that in the judgment of the investigator may interfere with the study results or the ability of subjects to complete the treatment period;
• Contact lens use anticipated during the study;
• Planned anterior segment surgery (e.g., cataract surgery or any surgery involving a limbal or corneal incision) in either eye during the study period;
• Meibography score at the screening visit of 4 (greater than 75% partial glands using the gestalt grading system);
• Known allergy to spandex or silicone;
• Pregnancy (verbal self-report) or breastfeeding;
• Participation in another clinical trial involving a therapeutic drug or device within the past 30 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a feasibility pilot trial with a small sample size and thus a formal sample size calculation was not performed. The statistical analysis will be a general analytical approach being descriptive in nature.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/03/2024
Actual
7/06/2024
Date of last participant enrolment
Anticipated
19/08/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
20
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315180 0
Commercial sector/Industry
Name [1] 315180 0
nthalmic Pty Ltd
Country [1] 315180 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
nthalmic Pty Ltd
Address
Suite L2, Level 3, Lakes Business Park, 2A Lord St, Botany NSW 2019
Country
Australia
Secondary sponsor category [1] 317204 0
None
Name [1] 317204 0
Address [1] 317204 0
Country [1] 317204 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314110 0
UNSW Human Ethics Committee
Ethics committee address [1] 314110 0
Ethics committee country [1] 314110 0
Australia
Date submitted for ethics approval [1] 314110 0
12/02/2024
Approval date [1] 314110 0
14/03/2024
Ethics approval number [1] 314110 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130446 0
Prof Fiona Stapleton
Address 130446 0
School of Optometry and Vision Science, Gate 14, Barker St UNSW Sydney NSW, 2052
Country 130446 0
Australia
Phone 130446 0
+61 2 9385 4375
Fax 130446 0
Email 130446 0
[email protected]
Contact person for public queries
Name 130447 0
Jacqueline Tan-Showyin
Address 130447 0
School of Optometry and Vision Science, Gate 14, Barker St UNSW Sydney NSW, 2052
Country 130447 0
Australia
Phone 130447 0
+61 2 9385 6551
Fax 130447 0
Email 130447 0
[email protected]
Contact person for scientific queries
Name 130448 0
Jacqueline Tan-Showyin
Address 130448 0
School of Optometry and Vision Science, Gate 14, Barker St UNSW Sydney NSW, 2052
Country 130448 0
Australia
Phone 130448 0
+61 2 9385 6551
Fax 130448 0
Email 130448 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.