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Trial registered on ANZCTR


Registration number
ACTRN12624000198527
Ethics application status
Approved
Date submitted
2/02/2024
Date registered
29/02/2024
Date last updated
25/08/2024
Date data sharing statement initially provided
29/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to assess the visual performance of novel myopia management spectacle films in short-sighted young adults
Scientific title
Prospective, randomised, crossover, bilateral wear, dispensing trial to assess the visual performance of prototype myopia management films in myopic adults
Secondary ID [1] 310580 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 331433 0
Condition category
Condition code
Eye 328178 328178 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The phone number for the principal investigator and contact person for public queries is the same. This is because both people are employees of nthalmic Pty Ltd, and this is nthalmic's only professional phone number. All queries will be fielded by an nthalmic employee, and then the query will be directed to the appropriate person.

This trial will be a prospective, bilateral, randomised, crossover clinical trial. Participants will wear one test single-vision spectacle with lens film and two control spectacles. The test film is made of polycarbonate and contains an edge pattern.
All spectacles will be worn for at least 5 days for a minimum of 6 hours/day. There is no limit to the maximum number of hours spectacles are worn.
Participants will choose a spectacle frame and all 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. Participants will be dispensed a new frame for each study spectacle, but an identical frame (same model, size, and colour), the same prescription, and the same optical centration will be used for each study spectacle.
Each participant will attend 5 visits comprising of Visit 1 (baseline), Visit 2 (Spectacle Dispensing visit 1), Visit 3 (Spectacle Assessment visit 1 + Spectacle Dispensing visit 2), Visit 4 (Spectacle Assessment visit 2 + Spectacle Dispensing visit 3) and Visit 5 (Spectacle Assessment visit 3). All 3 spectacles will be dispensed at the Dispensing visits, with no spectacles given at baseline (Visit 1) as this is the first visit, nor at Visit 5 as this is the final visit.
Visit 1, 3 and 4 will be approximately 60min duration and Visit 2 and 5 will be approximately 30min duration. The timing between visits will be approximately 2 weeks apart.
Visit 1 (Baseline) will comprise standard subjective refraction, measurement of visual acuity obtained with refraction and axial length measurements. A standard logarithm of the minimum angle of resolution (logMAR) visual acuity chart will be used.
Visit 2 (Spectacle Dispensing 1) will include visual acuity measurements using standard logMAR visual acuity charts.
Visit 3 (Spectacle Assessment 1/Dispense 2) will include visual acuity measurements using standard logMAR visual acuity charts and heterophoria measurements using standard phoria cards. Axial length will also be measured.
Visit 4 (Spectacle Assessment 2/Dispense 3) will include visual acuity measurements using standard logMAR visual acuity charts and heterophoria measurements using standard phoria cards. Axial length will also be measured.
Visit 5 (Spectacle Assessment 3) will include visual acuity measurements using standard logMAR visual acuity charts and heterophoria measurements using standard phoria cards. Axial length will also be measured.
All assessments will be carried out by an optometrist.
There is no 'wash-out' period between treatments.
Compliance will be assessed by verbal questioning of participants.
Questionnaires will be administered to participants at each Spectacle Assessment visit.
Intervention code [1] 326987 0
Treatment: Devices
Comparator / control treatment
One control will be a current commercially available myopia management spectacle lens and the other control will be a single vision spectacle lens.
Control group
Active

Outcomes
Primary outcome [1] 336051 0
Difference in subjective visual performance ratings between the control spectacles and the test spectacle. Participants will be asked to rate their vision with each spectacle lens on a non-validated 1-10 numeric rating scale.
Timepoint [1] 336051 0
Visit 3 (primary endpoint) - approximately 4 weeks post-enrolment
Visit 4 (primary endpoint) - approximately 6 weeks post-enrolment
Visit 5 (primary endpoint) - approximately 8 weeks post-enrolment
Secondary outcome [1] 426668 0
Difference in visual acuity measures between the control spectacles and the test spectacle. Visual acuity will be measured with standard logMAR chart at 6 metres and 40 cm. Visual acuities at different distances will be assessed as a composite outcome.
Timepoint [1] 426668 0
Visit 2 - approximately 2 weeks post-enrolment
Visit 3 - approximately 4 weeks post-enrolment
Visit 4 - approximately 6 weeks post-enrolment
Secondary outcome [2] 426669 0
Difference in distance and near phoria between the control spectacles and the test spectacle. Distance and near phoria will be measured using the modified Thorington technique.
Distance and near phoria will be assessed as a composite outcome.
Timepoint [2] 426669 0
Visit 3 - approximately 4 weeks post-enrolment
Visit 4 - approximately 6 weeks post-enrolment
Visit 5 - approximately 8 weeks post-enrolment
Secondary outcome [3] 429305 0
Differences in axial length between the control spectacles and the test spectacle. Axial length will be measured with a commercial instrument designed for the measurement.
Timepoint [3] 429305 0
Visit 3 - approximately 4 weeks post-enrolment
Visit 4 - approximately 6 weeks post-enrolment
Visit 5 - approximately 8 weeks post-enrolment

Eligibility
Key inclusion criteria
• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
• Be 18 to 45 years old, male or female.
• Willing to comply with the clinical trial as directed by the Investigator.
• Have ocular health findings considered to be “normal” and which would not prevent the participant from wearing spectacle lenses.
• Currently wearing or have the need to wear single-vision spectacles to correct myopia.
• Meet the following criteria based on subjective refraction at Baseline:
o Spherical equivalent less than or equal to -0.50 D
o Sphere component greater than or equal to -6.00 DS and less than or equal to 0 DS.
o Astigmatic component greater than or equal to -2.00 DC and less than or equal to 0 DC.
o Achieve at least 0.10 logMAR in each eye at 6 m and binocularly at 40 cm while wearing subjective distance refraction.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any pre-existing ocular irritation, injury, or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would cause vision fluctuations.
• 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. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
• Eye surgery within 12 weeks immediately prior to enrolment for this trial.
• Previous corneal refractive surgery.
• Known allergy or intolerance to ingredients in spectacle frames.
• Currently enrolled in another ocular clinical trial.
• Pregnancy at time of enrolment (verbal report sufficient)

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/07/2024
Actual
20/08/2024
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
28/01/2025
Actual
Sample size
Target
38
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 42353 0
2019 - Botany

Funding & Sponsors
Funding source category [1] 314790 0
Commercial sector/Industry
Name [1] 314790 0
nthalmic Pty Ltd
Country [1] 314790 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] 316777 0
None
Name [1] 316777 0
Address [1] 316777 0
Country [1] 316777 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313802 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 313802 0
Ethics committee country [1] 313802 0
Australia
Date submitted for ethics approval [1] 313802 0
02/02/2024
Approval date [1] 313802 0
15/03/2024
Ethics approval number [1] 313802 0

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

Contacts
Principal investigator
Name 129390 0
Dr Daniel Tilia
Address 129390 0
nthalmic Pty Ltd. Suite L2 Level 3 Lakes Business Park 2A Lord Street Botany NSW 2019
Country 129390 0
Australia
Phone 129390 0
+61 2 9037 7700
Fax 129390 0
Email 129390 0
[email protected]
Contact person for public queries
Name 129391 0
Kathy Laarakkers
Address 129391 0
nthalmic Pty Ltd. Suite L2 Level 3 Lakes Business Park 2A Lord Street Botany NSW 2019
Country 129391 0
Australia
Phone 129391 0
+61 2 9037 7700
Fax 129391 0
Email 129391 0
[email protected]
Contact person for scientific queries
Name 129392 0
Daniel Tilia
Address 129392 0
nthalmic Pty Ltd. Suite L2 Level 3 Lakes Business Park 2A Lord Street Botany NSW 2019
Country 129392 0
Australia
Phone 129392 0
+61 2 9037 7700
Fax 129392 0
Email 129392 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.