Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000319673
Ethics application status
Approved
Date submitted
17/03/2023
Date registered
24/03/2023
Date last updated
3/04/2024
Date data sharing statement initially provided
24/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to assess the short-term efficacy of spectacle films and contact lenses in myopic children
Scientific title
Prospective, cross-over pilot trial to assess the short-term efficacy of novel myopia management spectacle films and contact lenses when worn by children.
Secondary ID [1] 309217 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 329360 0
Condition category
Condition code
Eye 326304 326304 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a prospective, randomised cross-over clinical trial. Participants will choose to either wear either study products (contact lenses or spectacles: i.e., a participant will wear one or the other, not both) for 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 wear bilateral control contact lenses for a further 2 months.
Standard spectacles made with single vision lenses will be worn. A single vision spectacle lens will serve as the control, and a single vision spectacle lens with a spectacle film adhered on top of the spectacle lens containing an edge pattern will serve as the test. The spectacle film is made from polycarbonate material. Participants will control spectacle lenses bilaterally for 6 months. A cross-over will occur at 6 months and participants will wear spectacle test bilaterally for a further 6 months. . The minimum wear time for spectacles will be 5 days per week and 6 hours per day, with no daily maximum. Participants will choose a frame design from a designated pool of standard frames. Fittings will be confirmed by an optometrist. The distance power of the spectacle lenses will be power matched to the participant's myopic refractive error. At the conclusion of 12 months of wear, participants will wear bilateral control spectacle 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 (cross-over occurs), 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 subjective refraction, measurement of visual acuity obtained with refraction, and measurement of axial length. 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 2-9.
All assessments will be carried out by an optometrist. Participants will be instructed to wear study product as per the schedule and to return all study product. There is no 'wash-out' period at the cross-over (visit 5). Compliance will be assessed by verbal questioning of participants.
Intervention code [1] 325662 0
Treatment: Devices
Comparator / control treatment
For those wearing contact lenses, this is a contralateral study for the first 12 months and a bilateral study for the last 2 months. for those wearing contact lenses. Participants will wear a control lens in one eye and a test lens in the other eye. The allocation of test/control is randomised. For contact lenses, a single vision contact lens with no tinted edge pattern will serve as the control, and a single vision contact lens with a tinted edge pattern will serve as the test. At the 6-month visit, the test/control lens will be swapped between eyes. At the 12-month visit, participants will wear bilateral control for a further 2 months.
This is a bilateral study for those wearing spectacles. Participants will initially wear bilateral control followed by bilateral test. For spectacles, a single vision contact lens will serve as the control and a single vision spectacle lens with a spectacle film adhered to the top of the spectacle lens containing an edge pattern will serve as the test. Participants will wear bilateral control for the first 6 months, bilateral test for the next 6 months, and bilateral control for a further 2 months.
Control group
Active

Outcomes
Primary outcome [1] 334170 0
Difference in axial length between eyes when wearing the control and eyes when wearing the test. Axial length will be measured using a standard optical biometer.
Timepoint [1] 334170 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] 419642 0
Difference in visual acuity between the eye wearing the control and the eye wearing the test. Visual acuity will be measured using a standard Snellen letter chart..
Timepoint [1] 419642 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 [2] 419643 0
To assess for rebound effects in terms of rate of change of axial length when control compared to test. Axial length will be measured using a standard optical biometer.
Timepoint [2] 419643 0
At visit 9 (approximately 14.5 months post-enrolment)

Eligibility
Key inclusion criteria
Aged between 7-15 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
If wearing spectacle study product: Spectacle refraction of:
-sphere component between -0.50DS and -4.00DS inclusive and spherical equivalent less than or equal to -0.75D
-Astigmatic correction between 0DC and -1.50DC inclusive
If wearing contact lens study product: 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
15 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
If contact lenses are the chosen study product: 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 in axial length 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 are required to wear contact lenses.
The current clinical trial aims to enrol the same number of participants to wear spectacles (i.e., 30 participants). Assuming a 6-monthly progression of 0.20 mm with single vision (control) spectacles and a SD of 0.10 mm, a sample size of 24 will provide >90% power for a 2-tailed distribution to demonstrate a 40% reduction in axial length with the test spectacle lens compared to the contralateral control spectacle lens at the 5% level of significance.
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 visual acuity and rebound effects (the rate of change of axial length measurements between control and test products when control is worn after test). A similar random effects mixed model to the primary endpoint will be used for the analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/01/2024
Actual
29/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment postcode(s) [1] 39851 0
2019 - Botany
Recruitment postcode(s) [2] 41823 0
2046 - Five Dock
Recruitment postcode(s) [3] 41825 0
2095 - Manly
Recruitment postcode(s) [4] 41828 0
2154 - Castle Hill
Recruitment postcode(s) [5] 41826 0
2200 - Bankstown
Recruitment postcode(s) [6] 41821 0
2300 - Newcastle
Recruitment postcode(s) [7] 42185 0
3053 - Carlton
Recruitment postcode(s) [8] 42325 0
3053 - Carlton South
Recruitment postcode(s) [9] 41822 0
3175 - Dandenong
Recruitment postcode(s) [10] 41824 0
3630 - Shepparton
Recruitment postcode(s) [11] 41827 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 313406 0
Commercial sector/Industry
Name [1] 313406 0
nthalmic Pty Ltd
Country [1] 313406 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] 315172 0
None
Name [1] 315172 0
Address [1] 315172 0
Country [1] 315172 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312623 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 312623 0
123 Glen Osmond Rd
Eastwood
South Australia 5063
Ethics committee country [1] 312623 0
Australia
Date submitted for ethics approval [1] 312623 0
30/03/2023
Approval date [1] 312623 0
12/07/2023
Ethics approval number [1] 312623 0

Summary
Brief summary
There are two purposes to this trial. First, 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. Second, to assess the rate of change in axial length when wearing single vision spectacle lenses with a spectacle film containing an edge pattern and adhered on top of the spectacle lens and single vision spectacle lenses with no spectacle film (i.e., no edge pattern). Axial length will be measured with a standard optical biometer. Contact lenses are made from ocufilcon D and spectacle films are made from polycarbonate. 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 125322 0
Dr Daniel Tilia
Address 125322 0
nthalmic Pty Ltd
Suite L2, Level 3, Lakes Business Park,
2A Lord St.
Botany NSW 2019
Country 125322 0
Australia
Phone 125322 0
+61 290377700
Fax 125322 0
Email 125322 0
d.tilia@nthalmic.com
Contact person for public queries
Name 125323 0
Ms Kathleen Laarakkers
Address 125323 0
nthalmic Pty Ltd
Suite L2, Level 3, Lakes Business Park,
2A Lord St.
Botany NSW 2019
Country 125323 0
Australia
Phone 125323 0
+61 290377700
Fax 125323 0
Email 125323 0
k.laarakkers@nthalmic.com
Contact person for scientific queries
Name 125324 0
Dr Daniel Tilia
Address 125324 0
nthalmic Pty Ltd
Suite L2, Level 3, Lakes Business Park,
2A Lord St.
Botany NSW 2019
Country 125324 0
Australia
Phone 125324 0
+61 290377700
Fax 125324 0
Email 125324 0
d.tilia@nthalmic.com

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.