Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001790235
Ethics application status
Approved
Date submitted
25/10/2018
Date registered
1/11/2018
Date last updated
28/11/2019
Date data sharing statement initially provided
1/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A short-term evaluation of the accommodative responses of 6 contact lenses for myopia control and a control lens.
Scientific title
Prospective, single-masked, bilateral wear, cross-over, short-term non-dispensing clinical trial to compare accommodative and binocular function responses between various commercially available and prototype contact lens designs
Secondary ID [1] 296198 0
None
Universal Trial Number (UTN)
Trial acronym
Accommodative Response Trial (ART)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 309838 0
Ocular Accommodation 309839 0
Condition category
Condition code
Eye 308627 308627 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, single-masked, crossover, short-term clinical trial where participants will bilaterally wear for the duration of the visit, 2 commercially-available (and approved for use in Australia) and 3 prototype contact lenses used for myopia control and a single vision contact lens control (commercially-available and approved for use in Australia) with each lens to be worn at 6 different visits. There will be 7 scheduled visits for all participants.
The 6 lens types comprise:
• Commercially available (Australia) myopia control lenses (MiSight™) manufactured by Coopervision and made from omafilcon A material; base curve 8.7 mm, power range: -0.75 to -6.00 D.
• Commercially available (Australia) centre distance multifocal lenses (Proclear®) manufactured by Coopervision and made from omafilcon A material; base curve 8.7 mm, power range: -0.75 to -6.00 D, +2.00 add.
• Three prototype extended-depth-of-focus contact lenses manufactured by Pegavision and made from etafilcon A; base curve 8.5 mm, power range -0.75 to -6.00 D. Each different extended-depth-of-focus lens has a different series of smooth, non-monotonic, aperiodic, power variation across the optic zone that was designed by enhancing multiple spherical aberration terms.
• Commercially available (Australia) centre distance multifocal lenses (1 Day Acuvue® Moist) made from etafilcon A material; base curve 8.5 mm, power range: -0.75 to -6.00 D.
Visits will be performed by unmasked investigators and comprise contact lens fitting, assessment of acuity, assessment of contact lenses on eye with a slit-lamp biomicroscope (a specialized microscope for viewing the eye) and assessment of accommodative-convergence responses. Each visit will be approximately 60 minutes in duration. Baseline visits will comprise auto-refraction, subjective refraction with visual acuity measurement and ocular assessment with a slit-lamp biomicroscope.
Participants will wear their habitual vision correction in between wearing study lenses and a minimum of a night wash-out will be observed. All assessments will be carried out by an optometrist.
Participants will be asked to remove and dispose of the lenses at the end of each visit. There will be a minimum of a one-night washout between study lenses.
Intervention code [1] 312527 0
Treatment: Devices
Comparator / control treatment
Single vision lenses made from etafilcon A
Control group
Active

Outcomes
Primary outcome [1] 307587 0
Accommodative response as measured on an open-field auto-refractor.
Timepoint [1] 307587 0
All 6 assessment visits
Secondary outcome [1] 352373 0
Heterophoria: This will be assessed with distance and near Modified Thorington technique at 3m and 40cm respectively.
Timepoint [1] 352373 0
All 6 assessment visits
Secondary outcome [2] 352374 0
Near monocular accommodative facility: This will be assessed with +/- 2D flip spheres at 40cm, with the unmeasured eye occluded.
Timepoint [2] 352374 0
All 6 assessment visits

Eligibility
Key inclusion criteria
• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
• Be between 18-40 years old, male or female.
• 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 participant from safely wearing contact lenses.
• Be myopic with less than or equal to 1.00 D of cylindrical power in either eye.
• Be correctable to at least 0.20 logMAR in each eye with single vision contact lenses.
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, Sjögrens 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 enrollment.
• 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.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created through www.randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: Approximately 57 participants are required in order to demonstrate a statistically significant paired difference between lens designs in accommodative lag/lead of 0.25 DS ± 0.45 at the 5% level of significance and 80% power and accounting for post-hoc multiple comparisons. The sample size is adjusted for a 10% dropout rate. This sample size will have greater than 80% power to detect a significant paired difference between lens designs in phorias of 2 ± 2 prism dioptres.

Analysis:
a) Accommodative response (lead/lag) will be recorded as a numerical spherical equivalent (D). Data will be summarised as means ± standard deviations. No transformation is likely required. Accommodative lead/lag will be compared between each lens design and control lens types. The significance of the lens designs will be determined for each visit. Repeated effects linear mixed model with subject random intercepts or paired t tests will be employed for the analysis of accommodative lead/lag.

2) Phoria measurements will be recorded on a numerical scale of -28 to 28 prism dioptres in steps of 1. Data will be summarised as means ± standard deviations. No transformation is likely required. Phoria measurements will be compared between each lens design and control lens types. The significance of the lens designs will be determined for each visit. Repeated effects linear mixed model with subject random intercepts or paired t tests will be employed for the analysis of phoria measurements.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Trial terminated due to problems with the study instrument.
Date of first participant enrolment
Anticipated
31/07/2019
Actual
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
29/11/2019
Actual
Sample size
Target
57
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300788 0
Charities/Societies/Foundations
Name [1] 300788 0
Brien Holden Vision Institute
Country [1] 300788 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 4, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country
Australia
Secondary sponsor category [1] 300336 0
None
Name [1] 300336 0
Address [1] 300336 0
Country [1] 300336 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301572 0
Bellberry Limited
Ethics committee address [1] 301572 0
Ethics committee country [1] 301572 0
Australia
Date submitted for ethics approval [1] 301572 0
02/10/2018
Approval date [1] 301572 0
09/11/2018
Ethics approval number [1] 301572 0
HREC Approval Number: 2018-09-806

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

Contacts
Principal investigator
Name 87426 0
Ms Jennifer Sha
Address 87426 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 87426 0
Australia
Phone 87426 0
+61 2 93857537
Fax 87426 0
Email 87426 0
j.sha@brienholdenvision.org
Contact person for public queries
Name 87427 0
Kathy Laarakkers
Address 87427 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 87427 0
Australia
Phone 87427 0
+61 2 93857505
Fax 87427 0
Email 87427 0
k.laarakkers@brienholdenvision.org
Contact person for scientific queries
Name 87428 0
Jennifer Sha
Address 87428 0
Level 5, Rupert Myers Building Gate 14, Barker
Street University of New South Wales, NSW
2052
Country 87428 0
Australia
Phone 87428 0
+61 2 93857537
Fax 87428 0
Email 87428 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 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.