Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000997459
Ethics application status
Approved
Date submitted
25/08/2025
Date registered
9/09/2025
Date last updated
9/09/2025
Date data sharing statement initially provided
9/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Electronic versus microwave-heated eye masks for meibomian gland dysfunction
Scientific title
Prospective, randomized, parallel group trial comparing treatment efficacy of patient-applied electronic eye masks versus microwave-heated eye masks on lipid layer grade in adults with meibomian gland dysfunction
Secondary ID [1] 315170 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye disease 338606 0
Meibomian gland dysfunction 338607 0
Condition category
Condition code
Eye 334908 334908 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study intervention: The participant will apply a USB electronically-heated eye mask (Meibocare, New Zealand), to their own closed eyelids for 10-20 minutes (according to manufacturer instructions), twice daily, for 6 weeks. The target temperature during mask wear is 40 degrees Celsius which is anticipated to be reached in approximately 2 to 5 minutes. After applying heat for up to 20 minutes as instructed, the mask is removed. This is then followed by gentle digital eyelid massage which involves participants looking down first of all, and using their index fingers orientated horizontally to roll downwards over the upper eyelid from top to bottom 5 times, over about 10 seconds, both eyes at the same time to help express the oils at the eyelid margin. This process is repeated for the lower eyelids, during participant up-gaze, with the horizontal index finger, applied in a rolling motion from bottom to top, 5 times to the lower eyelids. Participant compliance with twice daily application of the heated mask followed by massage will be recorded in a participant diary.
Intervention code [1] 331787 0
Treatment: Devices
Comparator / control treatment
Active control:
The participants will apply a conventional warm bead eye mask (Therapearl, Bausch+Lomb, Canada) heated in a microwave according to manufacturer instructions (for up to 35 seconds for a 700 Watt microwave and up to 20 seconds for a 1250 Watt microwave) to their own closed eyelids for up to 20 minutes, twice daily, for 6 weeks. The target temperature during the bead mask application is 40 degrees Celsius which is anticipated to be reached in approximately 5 minutes. After applying heat for up to 20 minutes as instructed, the mask is removed. This is then followed by gentle digital eyelid massage which involves participants looking down first of all, and using their index fingers orientated horizontally to roll downwards over the upper eyelid from top to bottom 5 times, over about 10 seconds, both eyes at the same time to help express the oils at the eyelid margin. This process is repeated for the lower eyelids, during participant up-gaze, with the horizontal index finger, applied in a rolling motion from bottom to top, 5 times to the lower eyelids. Participant compliance with twice daily application of the heated mask followed by massage will be recorded in a participant diary.
Control group
Active

Outcomes
Primary outcome [1] 342530 0
Lipid layer grade (LLG)
Timepoint [1] 342530 0
6 weeks after baseline
Secondary outcome [1] 451175 0
Non-invasive tear breakup time (NIBUT)
Timepoint [1] 451175 0
6 weeks from baseline
Secondary outcome [2] 451176 0
Lipid layer thickness (LLT)
Timepoint [2] 451176 0
6 weeks after baseline
Secondary outcome [3] 451177 0
Tear meniscus height (TMH)
Timepoint [3] 451177 0
6 weeks after baseline
Secondary outcome [4] 451178 0
Tear evaporation rate (TER)
Timepoint [4] 451178 0
6 weeks after baseline
Secondary outcome [5] 451179 0
Tear osmolarity
Timepoint [5] 451179 0
6 weeks after baseline
Secondary outcome [6] 451180 0
Bulbar conjunctival hyperaemia grade
Timepoint [6] 451180 0
6 weeks after baseline
Secondary outcome [7] 451181 0
Treatment compliance
Timepoint [7] 451181 0
6 weeks after baseline

Eligibility
Key inclusion criteria
- 18 years or older
- Symptomatic of dry eye disease
- Clinical signs of meibomian gland dysfunction (MGD)
- Normal eyelid architecture
- Willing and able to follow the protocol
- Willing to not wear contact lenses (CL) or apply any eye drops within 12 hours of the study visits
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Use of contact lenses within 12 hours of study visits
- Active ocular allergy
- Refusal to be advised of incidental findings
- Current or planned pregnancy or lactation during the study
- Ocular surgery or dermatological treatments in the previous three months or planned during the study period
- History of ocular surgery (such as refractive or cataract surgery) in either eye within 3 months of study participation
- An ocular or systemic disorder or condition, current treatment, disease or trauma judged by the investigator to be incompatible with participation in the study

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)
Predetermined computer generated randomisation schedule will be used for allocation and this will be concealed from the masked investigator at all times, and concealed to the third party until the time of providing the allocated device, to avoid any risk of bias in treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generated using a computer-based random number allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: n=44 in total, for 2 parallel treatment groups to achieve a minimum of n=17 completed per group.
The designated outcome measures for the sample size calculation is lipid layer grade (LLG). Power calculations performed using G*Power (version 3.1) indicated that at least 17 subjects are needed to detect a clinically meaningful change of one lipid layer grade between the test and control eyes. This calculation is based on achieving 80% power (ß = 0.2) and a two-sided significance level of 5% (a = 0.05). Accounting for drop-outs, the study aims to enrol up to 22 participants in each group.

Statistical Analysis:
The difference between treatment outcomes and change from baseline will be assessed using two-way analysis of variance (ANOVA) for continuous variables with normal distributions confirmed by Kolmogorov-Smirnov testing (p > 0.05). Non-normally distributed continuous and ordinal data will be converted to rank-values prior to undergoing analysis. Categorical data (treatment satisfaction) will be compared using Fisher's exact test. All tests will be two-tailed and p less than 0.05 considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2025
Actual
Date of last participant enrolment
Anticipated
15/05/2026
Actual
Date of last data collection
Anticipated
2/10/2026
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment outside Australia
Country [1] 27314 0
New Zealand
State/province [1] 27314 0

Funding & Sponsors
Funding source category [1] 319745 0
University
Name [1] 319745 0
The University of Auckland
Country [1] 319745 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 322295 0
None
Name [1] 322295 0
Address [1] 322295 0
Country [1] 322295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318295 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 318295 0
Ethics committee country [1] 318295 0
New Zealand
Date submitted for ethics approval [1] 318295 0
28/11/2024
Approval date [1] 318295 0
17/12/2024
Ethics approval number [1] 318295 0
2024 EXP 21722

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

Contacts
Principal investigator
Name 143738 0
Prof Jennifer P Craig
Address 143738 0
Department of Ophthalmology, The University of Auckland, Private Bag 92019, Auckland 1142
Country 143738 0
New Zealand
Phone 143738 0
+6421853664
Fax 143738 0
Email 143738 0
[email protected]
Contact person for public queries
Name 143739 0
Jennifer P Craig
Address 143739 0
Department of Ophthalmology, The University of Auckland, Private Bag 92019, Auckland 1142
Country 143739 0
New Zealand
Phone 143739 0
+6421853664
Fax 143739 0
Email 143739 0
[email protected]
Contact person for scientific queries
Name 143740 0
Jennifer P Craig
Address 143740 0
Department of Ophthalmology, The University of Auckland, Private Bag 92019, Auckland 1142
Country 143740 0
New Zealand
Phone 143740 0
+6421853664
Fax 143740 0
Email 143740 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.