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Trial registered on ANZCTR


Registration number
ACTRN12623000823673
Ethics application status
Approved
Date submitted
14/07/2023
Date registered
1/08/2023
Date last updated
3/08/2024
Date data sharing statement initially provided
1/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to assess the retinal function of the eye when using a novel contact lens for myopia management
Scientific title
Evaluation of retinal ganglion cell function and ocular changes with A.R.R.E.S.T® contact lens design in emmetropic and myopic adults aged 18-25.
Secondary ID [1] 309977 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 330467 0
Condition category
Condition code
Eye 327318 327318 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, randomised, contralateral clinical trial. All participants will wear one test and one control contact lens simultaneously. The eye in which each the test and control is worn will be randomly determined. All contact lenses are made from a commercially available HEMA material (55% water) and are single use. The test will be a single vision contact lens with a tinted edge pattern and the control will be single vision contact lens with no tinted edge pattern. This study will recruit emmetropic and myopic participants. Emmetropic participants will wear plano power contact lenses and myopic participants will wear powered contact to correct their myopia. Participants will attend one single visit.
The study will comprise one visit with a total duration of approximately 80 minutes. All measurements will be performed by an optometrist. The initial measurements are performed prior to contact lens insertion, and comprise the photopic negative response (PhNR), pattern electroretinogram (PERG), and axial length. Contact lenses will be inserted after these measurements are taken. Participants will wear contact lenses and watch a greyscale television at 4 m in a room with an illumination of 700 lux for 10 minutes, after which the PhNR will be measured while wearing contact lenses. Participants will continue wearing contact lenses and watch a greyscale television at 4 m in a room with an illumination of 700 lux for a further 40 minutes, after which the PhNR and PERG will then be measured while wearing contact lenses. Adherence to watching the greyscale television will be monitored by research staff. Contact lenses will be removed, and the axial length will be measured.
Intervention code [1] 326392 0
Treatment: Devices
Comparator / control treatment
The control contact lens will be a standard single vision contact lens, i.e., the control lens will not have a tinted edge pattern..
Control group
Active

Outcomes
Primary outcome [1] 335188 0
Difference in PhNR between eyes. PhNR will be measured using a standard electro-retinographer.
Timepoint [1] 335188 0
Time 0 (prior to contact lens insertion)
Approximately 10 minutes after contact lens insertion (while wearing contact lenses).
Approximately 50 minutes after contact lens insertion (while wearing contact lenses).
Secondary outcome [1] 423420 0
Difference in PERG between eyes. PERG will be measured using a a standard electro-retinographer.
Timepoint [1] 423420 0
Time 0 (prior to contact lens insertion)
Approximately 50 minutes after contact lens insertion (while wearing contact lenses).
Secondary outcome [2] 424194 0
Axial length
Difference in axial length between eyes. Axial length will be measured using a standard ocular biometer.
Timepoint [2] 424194 0
Time 0 (prior to contact lens insertion)
Approximately 50 minutes after contact lens insertion (contact lenses removed before measurement).

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 18-25 (inclusive) 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 a spherical equivalent refraction of <-0.75D (myopic group) OR between +/-0.50D (non-myopic group)
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Refractive error (myopia, hyperopia or astigmatism) greater than 3D
Difference of refractive error between the eye greater than 1D
Any history of significant eye injury or surgery
Any major systemic disease

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
Other
Other design features
All participants will wear one test and one control contact lens simultaneously. The eye in which each the test and control is worn will be randomly determined.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A pilot study conducted at Flinders University showed the mean difference in PhNR between eyes while wearing test and control contact lenses to be 0.888 micro volts with a standard deviation of 1.214 micro volts. If this is a true difference between test and control, this study requires 30 participants to wear the test and control in each eye to be able to reject the null hypothesis with 80% power. The Type I error is set at 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2023
Actual
16/11/2023
Date of last participant enrolment
Anticipated
18/09/2023
Actual
13/03/2024
Date of last data collection
Anticipated
18/09/2023
Actual
13/03/2024
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 40634 0
5042 - Flinders University

Funding & Sponsors
Funding source category [1] 314151 0
Commercial sector/Industry
Name [1] 314151 0
nthalmic Pty Ltd
Country [1] 314151 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] 316070 0
None
Name [1] 316070 0
Address [1] 316070 0
Country [1] 316070 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313286 0
Human Research Ethics Committee, Flinders University
Ethics committee address [1] 313286 0
Ethics committee country [1] 313286 0
Australia
Date submitted for ethics approval [1] 313286 0
24/10/2022
Approval date [1] 313286 0
16/11/2022
Ethics approval number [1] 313286 0
5781

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

Contacts
Principal investigator
Name 127606 0
Dr Ranjay Chakraborty
Address 127606 0
College of Nursing and Health Science
Flinders University
Sturt Road, Bedford Park, SA 5042
Country 127606 0
Australia
Phone 127606 0
+618 7221 8708
Fax 127606 0
Email 127606 0
ranjay.chakraborty@flinders.edu.au
Contact person for public queries
Name 127607 0
Jennie Diec
Address 127607 0
nthalmic Pty Ltd
Suite L2, Level 3, Lakes Business Park,
2A Lord St.
Botany NSW 2019
Country 127607 0
Australia
Phone 127607 0
+61 2 9037 7700
Fax 127607 0
Email 127607 0
j.diec@nthalmic.com
Contact person for scientific queries
Name 127608 0
Daniel Tilia
Address 127608 0
nthalmic Pty Ltd
Suite L2, Level 3, Lakes Business Park,
2A Lord St.
Botany NSW 2019
Country 127608 0
Australia
Phone 127608 0
+61 2 9037 7700
Fax 127608 0
Email 127608 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.