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Trial registered on ANZCTR


Registration number
ACTRN12625000098437p
Ethics application status
Not yet submitted
Date submitted
15/01/2025
Date registered
30/01/2025
Date last updated
30/01/2025
Date data sharing statement initially provided
30/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to assess the short-term efficacy of contact lenses in myopic children
Scientific title
Prospective, cross-over trial to assess the short-term efficacy of novel myopia management contact lenses in myopic children
Secondary ID [1] 313703 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 336293 0
Condition category
Condition code
Eye 332831 332831 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a prospective, randomised contralateral wear, cross-over clinical trial. Participants will wear contact lenses for up to 14 months.
Contact lenses are made from ocufilcon D material and are replaced daily. A single vision contact lens will serve as the control, and a single vision contact lens with a tinted edge pattern will serve as the test. Contact lens wear will be contralateral, and the eye first wearing the control or test will be randomly determined. Contact lenses will be worn for 6 months. A cross-over will occur at 6 months so that the eye wearing the control will wear the test, and the eye wearing the test will wear the control. Participants will wear contact lenses for a further 6 months. The minimum wear time for contact lenses will be 5 days per week and 6 hours per day to a maximum of 16 hours per day. The distance power of the contact lenses will be power matched to the participant’s myopic refractive error. At the conclusion of 12 months of wear, participants will bilaterally wear single vision contact lenses for a further 2 months.

Each participant will attend 9 visits comprising visit 1 (baseline) visit 2 (study product dispensed), visit 3, visit 4, visit 5 (cross-over occurs), visit 6, visit 7, visit 8 (study product wear stopped, and single vision worn) and visit 9.
Visit 1 will be approximately 45 min duration and visits 2-9 will be approximately 30 min duration. The timing between visits 1 and 2 will be approximately 2 weeks. The timing between visits 2-9 will be approximately 2 months.
Visit 1 will comprise standard cycloplegic autorefraction, subjective refraction, measurement of visual acuity obtained with refraction and measurement of axial length. Cycloplegia is a standard procedure used during an eye examination to relax focusing and is induced by instilling tropicamide eye drops. Tropicamide will also dilate the pupils. A standard Snellen visual acuity chart will be used to measure visual acuity and a standard optical biometer will be used to measure axial length. Visual acuity with study product and axial length will be measured at visits 2-8, cycloplegic autorefraction will be measured at visits 5 and 8. Visual acuity with single vision correction and axial length will be measured at visit 9.
All assessments will be carried out by an optometrist. Participants will be instructed to wear study products as per the schedule and to return all study products There is no 'wash-out' period at the cross-over (visit 5). Compliance will be assessed by verbal questioning of participants.
Intervention code [1] 330299 0
Treatment: Devices
Comparator / control treatment
The control is a standard, single-vision contact lens.
Control group
Active

Outcomes
Primary outcome [1] 340357 0
Difference in axial length between the eye wearing the control and the eye wearing the test.
Timepoint [1] 340357 0
At visit 2 (approximately 2 weeks post-enrolment)
At visit 3 (approximately 2.5 months post-enrolment)
At visit 4 (approximately 4.5 months post-enrolment)
At visit 5 (approximately 6.5 months post-enrolment)
At visit 6 (approximately 8.5 months post-enrolment)
At visit 7 (approximately 10.5 months post-enrolment)
At visit 8 (approximately 12.5 months post-enrolment)
Secondary outcome [1] 443816 0
Difference in cycloplegic spherical equivalent autorefraction between test and control
Timepoint [1] 443816 0
At visit 5 (approximately 6.5 months post-enrolment)
At visit 8 (approximately 12.5 months post-enrolment)
Secondary outcome [2] 443817 0
Difference in visual acuity between the eye wearing the control and the eye wearing the test
Timepoint [2] 443817 0
At visit 2 (approximately 2 weeks post-enrolment)
At visit 3 (approximately 2.5 months post-enrolment)
At visit 4 (approximately 4.5 months post-enrolment)
At visit 5 (approximately 6.5 months post-enrolment)
At visit 6 (approximately 8.5 months post-enrolment)
At visit 7 (approximately 10.5 months post-enrolment)
At visit 8 (approximately 12.5 months post-enrolment)
Secondary outcome [3] 443818 0
To assess for rebound effects in terms of rate of change of axial length when wearing single vision compared to test lenses
Timepoint [3] 443818 0
At visit 9 (approximately 14.5 months post-enrolment)

Eligibility
Key inclusion criteria
Aged between 7-13 years inclusive
Have read, understood and signed informed assent
Parents have read, understood and signed informed consent
Adhere to study requirements, wear study products and maintain visit schedule
Have good general health and normal ocular health
Best-corrected high contrast visual acuity of 6/7.6 or better in each eye
Spectacle refraction of:
-sphere component less than or equal to -0.50D and spherical equivalent between -0.75D and -4.00D inclusive
-Astigmatic correction between 0DC and -1.00DC inclusive
Minimum age
7 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current or use within 12 months of myopia management options including but not limited to
-Bifocal/multifocal spectacles or contact lenses
-Orthokeratology
-Atropine/pirenzepine pharmacological agents
Contraindications to contact lens wear, including any pre-existing ocular irritation, injury, or condition (including infection or disease) of the cornea, conjunctiva or eyelids
Any systemic disease that adversely affects ocular health e.g., diabetes, Graves’ disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus.
Use of or a need for concurrent category S3 and above ocular medication at enrolment.
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Keratoconus
Manifest strabismus
Known allergy or intolerance to ingredients in any of the clinical trial products.
Currently enrolled in another clinical trial.

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)
Allocation 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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparisons will be between eyes wearing control or test product. Assuming a 6-monthly progression of 0.16 mm with single vision (control) contact lenses and a standard deviation (SD) of 0.10 mm, 24 participants are required to detect a 40% reduction in axial length with the test contact lens compared to the contralateral control contact lens at the 5% level of significance and 80% power for a 2-tailed distribution. Assuming a 20% drop-out, a minimum of 30 participants in total are required to wear contact lenses.
Primary and secondary outcomes will be summarised as means ± standard deviation. For the primary outcome (axial length), data from multiple visits and both eyes within the same participant are available for the analysis. Therefore, to account for the correlation of data collected within the same participant, a random effects mixed model will be used to compare the treatment effect on the primary endpoint over the study period. Participant and eye (nested within participant) will be included as random effects in the model to account for the correlation between repeated measures and between eyes within the same participant. The treatment effect (difference in change from initial dispense in axial length between each test product and control product) and its two-sided 95% confidence intervals at each assessment visit will be estimated from the model.
The secondary endpoints comprise, cycloplegic autorefraction, visual acuity and the rate of change of axial length measurements between single vision correction and test products. A similar random effects mixed model to the primary endpoint will be used for the analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
1/04/2025
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26821 0
New Zealand
State/province [1] 26821 0

Funding & Sponsors
Funding source category [1] 318169 0
Commercial sector/Industry
Name [1] 318169 0
nthalmic Pty Ltd
Country [1] 318169 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
nthalmic Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320550 0
None
Name [1] 320550 0
Address [1] 320550 0
Country [1] 320550 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316816 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 316816 0
https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
Ethics committee country [1] 316816 0
New Zealand
Date submitted for ethics approval [1] 316816 0
30/01/2025
Approval date [1] 316816 0
Ethics approval number [1] 316816 0

Summary
Brief summary
The main purpose of this study is to assess the rate of change in axial length when wearing single vision contact lenses with an edge pattern against single vision contact lenses with no edge pattern. Axial length will be measured with a standard optical biometer. Contact lenses are made from ocufilcon D. It is hypothesised that study products containing edge patterns will have a lower rate of change in axial length.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139098 0
Dr Jagrut Lallu
Address 139098 0
New Zealand Eye Research Centre, 37 Lake Road Frankton Hamilton 3204
Country 139098 0
New Zealand
Phone 139098 0
+6421786763
Fax 139098 0
Email 139098 0
[email protected]
Contact person for public queries
Name 139099 0
Jessica Wood
Address 139099 0
New Zealand Eye Research Centre, 37 Lake Road Frankton Hamilton 3204
Country 139099 0
New Zealand
Phone 139099 0
+64078473195
Fax 139099 0
Email 139099 0
[email protected]
Contact person for scientific queries
Name 139100 0
Daniel Tilia
Address 139100 0
nthamic Pty Ltd, Level 3, 2A Lord St, Botany NSW 2019
Country 139100 0
Australia
Phone 139100 0
+61 290377700
Fax 139100 0
Email 139100 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
Individual participant data will not be published. However, trial results, recorded as group means plus/minus SD and their statistical analysis may be published in scientific journals.


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.