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Trial registered on ANZCTR


Registration number
ACTRN12623000781640
Ethics application status
Approved
Date submitted
30/06/2023
Date registered
18/07/2023
Date last updated
6/07/2024
Date data sharing statement initially provided
18/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to assess the visual performance of myopia management contact lenses in adults
Scientific title
Prospective, randomised, cross-over, bilateral wear, dispensing trial to assess the visual performance of prototype myopia management contact lenses in myopic, adult, contact lens wearers
Secondary ID [1] 309686 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 330065 0
Condition category
Condition code
Eye 326966 326966 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, bilateral clinical trial. All participants will be randomised to wear three different soft contact lenses. The contact lenses are made from either ocufilcon D or omafilcon A and are replaced daily. A single vision contact lens and a myopia management contact lens will serve as the controls and a single vision contact lens with a tinted edge pattern will served as the test.
Contact lens wear will be for a minimum of 5 days.
Each participant will attend 4 visits comprising:
Visit 1 (Baseline/Dispensing 1): Standard subjective refraction, visual acuity, ocular health, and axial length will be measured. The first randomised contact lens will be fitted and dispensed. Visual acuity and lens fitting will be measured, and lens surface will be assessed. The approximate duration is 60 minutes.
Visit 2 (Assessment 1/Dispensing 2): Assessment of the first dispensed contact lenses will occur and involve subjective assessment, visual acuity, binocular vision, lens fitting, lens surface, ocular health, and axial length measurements. The second randomised contact lens will be fitted and dispensed. Visual acuity and lens fitting will be measured, and lens surface will be assessed. The approximate duration is 60 minutes.
Visit 3 (Assessment 2/Dispensing 3): Assessment of the second dispensed contact lenses will occur and involve subjective assessment, visual acuity, binocular vision, lens fitting, lens surface, ocular health, and axial length measurements. The third randomised contact lens will be fitted and dispensed. Visual acuity and lens fitting will be measured, and lens surface will be assessed. The approximate duration is 60 minutes.
Visit 4 (Assessment 3): Assessment of the third dispensed contact lenses will occur and involve subjective assessment, visual acuity, binocular vision, lens fitting, lens surface, ocular health, and axial length measurements. The approximate duration is 30 minutes.
Non-validated questionnaires will be used for subjective assessment of visual performance. Visual acuity will be measured using a standard Snellen letter chart. A standard optical biometer will be used to measure axial length. A slit lamp biomicroscope will be used to assess ocular health, contact lens fitting, and the contact lens surface. Binocular vision measurements comprise heterophoria, monocular accommodative facility, and accommodative response, and will be measured utilising standardised optometric techniques using standard phoria cards, standard flippers, and a standard open-field autorefractor, respectively.
All visits will be performed by an optometrist. Compliance will be assessed via questionnaires and verbal questioning.
Intervention code [1] 326131 0
Treatment: Devices
Comparator / control treatment
This study comprises of two control contact lens and one test contact lens.
The control contact lenses are:
1. Current marketed single vision contact lens
2. Current marketed myopia management contact lens
Control group
Active

Outcomes
Primary outcome [1] 334802 0
Difference in subjective visual performance between test and control contact lenses. Participants will rate their subjective visual performance using a non-validated 1-10 numeric rating scale in 1-point steps.
Timepoint [1] 334802 0
At Visit 2 (approximately 1 weeks post-enrolment)
At Visit 3 (approximately 2 weeks post-enrolment)
At Visit 4 (approximately 3 weeks post-enrolment)
Secondary outcome [1] 422128 0
Difference in visual acuity between test and control contact lenses. Visual acuity will be measured using a standard logMAR visual acuity chart.
Timepoint [1] 422128 0
At Visit 2 (approximately 1 weeks post-enrolment)
At Visit 3 (approximately 2 weeks post-enrolment)
At Visit 4 (approximately 3 weeks post-enrolment)
Secondary outcome [2] 422129 0
Difference in axial length between test and control contact lenses. Axial length will be measured using an optical coherence biometer.
Timepoint [2] 422129 0
At Visit 2 (approximately 1 weeks post-enrolment)
At Visit 3 (approximately 2 weeks post-enrolment)
At Visit 4 (approximately 3 weeks post-enrolment)
Secondary outcome [3] 422130 0
Difference in distance and near phoria between test and control contact lenses. Distance and near phoria will be measured using the modified Thorington technique. Distance and near phoria will be assessed as a composite outcome.
Timepoint [3] 422130 0
At Visit 2 (approximately 1 weeks post-enrolment)
At Visit 3 (approximately 2 weeks post-enrolment)
At Visit 4 (approximately 3 weeks post-enrolment)
Secondary outcome [4] 422131 0
Difference in monocular accommodative facility between test and control contact lenses. Monocular accommodative facility will be measured using a standard +/-2.00 D flipper and measured for one minute.
Timepoint [4] 422131 0
At Visit 2 (approximately 1 weeks post-enrolment)
At Visit 3 (approximately 2 weeks post-enrolment)
At Visit 4 (approximately 3 weeks post-enrolment)
Secondary outcome [5] 422132 0
Difference in the lens surface characteristics (lens wettability and deposition) between test and control contact lenses. Lens surface will be assessed using a slitlamp biomicroscope.
Timepoint [5] 422132 0
At Visit 2 (approximately 1 weeks post-enrolment)
At Visit 3 (approximately 2 weeks post-enrolment)
At Visit 4 (approximately 3 weeks post-enrolment)
Secondary outcome [6] 424228 0
Difference in accommodative response between test and control contact lenses.
Accommodative response will be measured using an open-field autorefractor.
Timepoint [6] 424228 0
At Visit 2 (approximately 1 weeks post-enrolment)
At Visit 3 (approximately 2 weeks post-enrolment)
At Visit 4 (approximately 3 weeks post-enrolment)
Secondary outcome [7] 424229 0
Difference in lens fitting between test and control contact lenses. Lens fitting will be assessed using a slitlamp biomicroscope.
Timepoint [7] 424229 0
At Visit 2 (approximately 1 weeks post-enrolment)
At Visit 3 (approximately 2 weeks post-enrolment)
At Visit 4 (approximately 3 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 aged at least 18 years and less than 40 years, 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 safely wearing contact lenses.
Have experience with wearing contact lenses.
Have myopia greater than 0.75 D and no more than 6.00 D.
Have best-corrected visual acuity at least 6/7.5 (0.1 logMAR)
Minimum age
18 Years
Maximum age
40 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 preclude contact lens fitting and safe wearing of contact lenses.
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.
Use of or a need for concurrent category S3 and above ocular medication at enrolment.
Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
NB: Systemic antihistamines are allowed on an “as needed basis”, provided they are not used prophylactically while wearing study lenses.
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Previous corneal refractive surgery.
Contraindications to contact lens wear.
Known allergy or intolerance to ingredients in any of the clinical trial products.
Currently enrolled in another 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 randomised 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
This study is to compare the difference in subjective visual performance (subjective ratings) between the Test and each Control. There are two main comparisons in the study (Test vs. Control 1, Test vs. Control 2) at the final analysis, and therefore the sample size calculation for the type I error is set at the level of 0.025 (0.05/2) for each comparison to account for the multiple comparisons. Based on a review of the literature (Tilia et al., 2023), it is assumed that that the difference between Test and either Control is a clinically relevant 1.0 unit (Papas et al., 2011) and the SD is 1.8 units. To achieve a test power of 80% based on a t-test (two-sided) for each comparison, 34 participants are needed to wear each contact lens. Assuming a 10% drop-out, a minimum of 38 participants are required to be enrolled.
The primary endpoint is the difference in subjective ratings after at least 5 days of wear between the Test and each Control. Data from multiple visits 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 primary endpoint over the study period. Participant will be included as random effects in the model to account for the correlation between repeated measures and within the same participant. The difference in subjective ratings after at least 5 days of wear its two-sided 95% confidence intervals at each assessment visit will be estimated from the model.
The secondary endpoints include difference between Test and each Control for visual acuity performance, change from baseline in axial length, binocular vision measurements, lens fitting measurements, and lens surface measurements. Depending on the actual variables measured (continuous data), similar random effects mixed model to the primary endpoint will be used for the analysis. Where data is available from two eyes (e.g., axial length), 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 results from secondary endpoints will provide supportive evidence.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/10/2023
Actual
7/11/2023
Date of last participant enrolment
Anticipated
Actual
17/05/2024
Date of last data collection
Anticipated
Actual
7/06/2024
Sample size
Target
38
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 40405 0
2019 - Botany

Funding & Sponsors
Funding source category [1] 313881 0
Commercial sector/Industry
Name [1] 313881 0
nthalmic Pty Ltd
Country [1] 313881 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] 315727 0
None
Name [1] 315727 0
Address [1] 315727 0
Country [1] 315727 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313028 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 313028 0
123 Glen Osmond Rd
Eastwood
South Australia 5063
Ethics committee country [1] 313028 0
Australia
Date submitted for ethics approval [1] 313028 0
10/07/2023
Approval date [1] 313028 0
03/08/2023
Ethics approval number [1] 313028 0
2023-07-796

Summary
Brief summary
The purpose of this study is to assess the visual performance of prototype contact lenses with a tinted edge pattern compared to commercially available single vision contact lens and myopia management contact lens.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126734 0
Dr Daniel Tilia
Address 126734 0
nthalmic Pty Ltd.
Suite L2 Level 3 Lakes Business Park
2A Lord Street Botany NSW 2019
Country 126734 0
Australia
Phone 126734 0
+61 2 9037 7700
Fax 126734 0
Email 126734 0
[email protected]
Contact person for public queries
Name 126735 0
Kathleen Laarakkers
Address 126735 0
nthalmic Pty Ltd.
Suite L2 Level 3 Lakes Business Park
2A Lord Street Botany NSW 2019
Country 126735 0
Australia
Phone 126735 0
+61 2 9037 7700
Fax 126735 0
Email 126735 0
[email protected]
Contact person for scientific queries
Name 126736 0
Daniel Tilia
Address 126736 0
nthalmic Pty Ltd.
Suite L2 Level 3 Lakes Business Park
2A Lord Street Botany NSW 2019
Country 126736 0
Australia
Phone 126736 0
+61 2 9037 7700
Fax 126736 0
Email 126736 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.