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Trial registered on ANZCTR


Registration number
ACTRN12618000242224
Ethics application status
Approved
Date submitted
6/02/2018
Date registered
14/02/2018
Date last updated
27/05/2019
Date data sharing statement initially provided
3/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Contralateral myopia progression trial
Scientific title
Prospective, contralateral, randomised, crossover dispensing clinical trial
to compare the myopia progression rate between a myopia control contact
lens and single vision contact lenses
Secondary ID [1] 293974 0
None
Universal Trial Number (UTN)
U1111-1209-0267
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 306485 0
Condition category
Condition code
Eye 305583 305583 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will wear a test lens in one eye and a single vision contact lens in the other eye over 12 months (two stages of 6 month duration). Lens types will be swapped between eyes after 6 months from the first stage to the second stage. There is no wash out period between stages. Contact lenses will be used on a daily wear, daily disposable wearing schedule with lens wear for all waking periods and all days of the week (minimum 8 hours/day, 6 days/week). Instructions will be provided by registered optometrists.
Test lenses are prototype contact lenses (novel optical designs) manufactured in etafilcon A or methafilcon A. The two lens materials are due to resource availability. Ideally, participants will use only one material for the duration of the study so long as stock is sufficient.
To monitor compliance, participants or their parent/guardian will complete a questionnaire each day noting how many hours the lenses were worn, or if not worn, why they were not worn.
Intervention code [1] 300246 0
Treatment: Devices
Comparator / control treatment
Control lenses are 1-Day Acuvue Moist (Johnson & Johnson Vision Care) to be worn in the other eye.
Control group
Active

Outcomes
Primary outcome [1] 304704 0
Myopic progression expressed as the change in cycloplegic autorefraction spherical equivalent from baseline. Measured with Nidek Tonoref.
Timepoint [1] 304704 0
6 months, 12 months (primary timepoint) after baseline.
Secondary outcome [1] 342858 0
Myopic progression expressed as the change in axial length from baseline. Measured with Haag-Streit Lenstar.
Timepoint [1] 342858 0
6 months, 12 months after baseline.

Eligibility
Key inclusion criteria
Aged between 6 years to 17 years (6 years and 17 years inclusive);
Spherical equivalent -0.75 D to -3.50 D with cylinder no more than -1.00 D; anisometropia of less than or equal to 0.75D
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent or have a parent / guardian who is able to give informed consent on the participant’s behalf.
Be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
Have ocular health findings considered to be “normal” and which would not prevent the subject from safely wearing contact lenses;
Have vision correctable to at least 6/9.5 or better in each eye with study contact lenses.
Minimum age
6 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants enrolled in the trial must NOT have:
pre-existing ocular irritation that would preclude contact lens fitting;
any systemic or ocular condition or ocular injury that may preclude safe wearing of contact lenses;
undergone corneal refractive surgery;
Keratoconus
a known allergy to, or a history of intolerance to cyclopentolate or topical anaesthetics;
at baseline, astigmatism more than 1.00 D in either eye;
had strabismus and/or current ongoing amblyopia;
any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity;
current orthoptic treatment or vision training;
eye injury or surgery within 12 weeks immediately prior to enrolment for this trial;
undergone atropine treatment for myopia control;
worn bifocal or progressive addition spectacles or anti-myopia contact lenses previously;
worn orthokeratology lenses previously;
require anticholinergic medication for gastrointestinal or other conditions;
at baseline, be anisometropic by more than 0.75D;

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation plan will be generated as per company SOPs and generated from
http://www.randomization.com/. The website’s second random generator will be used to create a random permutation of lens types for each participant. The random generator will allocate the order of dispensing the test or control lens for stages 1 and 2 for each participant’s right eye. The left eye will be dispensed with the other unallocated lens within that stage. Stages 1 and 2 corresponds to the first and second six months of the study. Every participant will wear test and control lens on each eye across the two stages of the study. The generated randomisation list will be copied from the website by the biostatistician and applied through the Clinic Data Management system.
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
Prior studies conducted by the Brien Holden Vision Institute in Australia and China indicated that the estimated progression of myopia at the end of 6-months in a population of 7 to 15year olds using control contact lenses was 0.33±0.24D and 0.38±0.27D respectively. Assuming the larger standard deviation and setting a clinically
significant difference of 35% reduction compared to control, approximately 45 successfully enrolled participants are required in order to demonstrate a statistically significant paired difference in myopia progression of 0.13±0.27 D between test and control groups at the 5% level of significance with 80% power and a 2-tailed distribution. The estimated sample size is adjusted for a dropout rate of 20% over 1 year.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/03/2018
Actual
28/05/2018
Date of last participant enrolment
Anticipated
Actual
4/10/2018
Date of last data collection
Anticipated
24/10/2019
Actual
Sample size
Target
45
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298605 0
Other Collaborative groups
Name [1] 298605 0
Brien Holden Vision Institute
Country [1] 298605 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Brien Holden Vision Institute
Address
Level 4, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 297762 0
None
Name [1] 297762 0
Address [1] 297762 0
Country [1] 297762 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299566 0
Bellberry Limited
Ethics committee address [1] 299566 0
Ethics committee country [1] 299566 0
Australia
Date submitted for ethics approval [1] 299566 0
10/01/2018
Approval date [1] 299566 0
15/02/2018
Ethics approval number [1] 299566 0

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

Contacts
Principal investigator
Name 80858 0
Ms Jennifer Sha
Address 80858 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 80858 0
Australia
Phone 80858 0
+61 2 9385 7516
Fax 80858 0
Email 80858 0
j.sha@brienholdenvision.org
Contact person for public queries
Name 80859 0
Kassandra Wagenfuehr
Address 80859 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 80859 0
Australia
Phone 80859 0
+61 2 9385 7516
Fax 80859 0
Email 80859 0
k.wagenfuehr@brienholdenvision.org
Contact person for scientific queries
Name 80860 0
Jennifer Sha
Address 80860 0
Brien Holden Vision Institute
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 80860 0
Australia
Phone 80860 0
+61 2 9385 7516
Fax 80860 0
Email 80860 0
j.sha@brienholdenvision.org

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 published. However trial results, recorded as 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.