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Trial registered on ANZCTR


Registration number
ACTRN12620000159954
Ethics application status
Approved
Date submitted
29/01/2020
Date registered
13/02/2020
Date last updated
30/11/2023
Date data sharing statement initially provided
13/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
MALCOLM - MultifocAL COntact Lenses for Myopia
Scientific title
MALCOLM - MultifocAL COntact Lenses for Myopia and their effect on axial length elongation in children
Secondary ID [1] 291706 0
None
Universal Trial Number (UTN)
Trial acronym
MALCOLM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 316014 0
Condition category
Condition code
Eye 314289 314289 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ACUVUE OASYS for PRESBYOPIA contact lenses prescribed by a registered optometrist to children with myopia will be worn in one eye for 10 hours a day for one year. These lenses will be provided to participants by the study. The lens power will be determined at the discretion of the optometrist. These lenses will be in different packaging than lenses for the other eye.
Intervention code [1] 316673 0
Treatment: Devices
Comparator / control treatment
MiSight 1 Day contact lenses prescribed by a registered optometrist to children with myopia will be worn in the contralateral eye for 10 hours a day for one year. This lens has a different design and material compared to the intervention lens and will be provided to participants by the study. The lens power will be determined at the discretion of the optometrist. These lenses will be in different packaging than lenses for the other eye.
Control group
Active

Outcomes
Primary outcome [1] 322676 0
Change in Axial Length between two eyes measured by laser interferometry (IOL Master)
Timepoint [1] 322676 0
1 month, 3 months, 6 months and 12 months (primary timepoint) post intervention commencement
Primary outcome [2] 322677 0
Change in Autorefraction between two eyes as measured by autorefractor
Timepoint [2] 322677 0
1 month, 3 months, 6 months and 12 months (primary timepoint) post intervention commencement
Secondary outcome [1] 379269 0
Change in Corneal topography measurements between two eyes as measured by corneal topographer (Oculus Keratograph, Medmont E300)
Timepoint [1] 379269 0
1 month, 3 months, 6 months and 12 months (primary timepoint) post intervention commencement
Secondary outcome [2] 379275 0
Change in subjective refraction between two eyes using phoropter or trial frame
Timepoint [2] 379275 0
1 month, 3 months, 6 months and 12 months (primary timepoint) post intervention commencement
Secondary outcome [3] 379276 0
Change in amplitude of accommodation between the two eyes with push up test
Timepoint [3] 379276 0
1 month, 3 months, 6 months and 12 months (primary timepoint) post intervention commencement
Secondary outcome [4] 379277 0
Change in anterior chamber depth between the two eyes with laser interferometry (IOL Master) and optical coherence tomography (Casia SS-1000)
Timepoint [4] 379277 0
1 month, 3 months, 6 months and 12 months (primary timepoint) post intervention commencement
Secondary outcome [5] 379278 0
Change in distance and near vision between the two eyes using visual acuity charts
Timepoint [5] 379278 0
1 month, 3 months, 6 months and 12 months (primary timepoint) post intervention commencement
Secondary outcome [6] 379682 0
Change in pupillary measurements as measured by pupillometer
Timepoint [6] 379682 0
1 month, 3 months, 6 months and 12 months (primary timepoint) post intervention commencement
Secondary outcome [7] 380085 0
Change in lens thickness between the two eyes with laser interferometry (IOL Master).
Timepoint [7] 380085 0
1 month, 3 months, 6 months and 12 months (primary timepoint) post intervention commencement
Secondary outcome [8] 380090 0
Change in corneal radii between the two eyes with laser interferometry (IOL Master).
Timepoint [8] 380090 0
1 month, 3 months, 6 months and 12 months (primary timepoint) post intervention commencement
Secondary outcome [9] 391752 0
Change in posterior segment depth measurements with optical coherence tomography
Timepoint [9] 391752 0
1 month, 3 months, 6 months and 12 months (primary timepoint) post intervention commencement

Eligibility
Key inclusion criteria
1) Aged 6-12 years (inclusive)
2) Is willing to wear soft contact lenses daily
3) Spherical equivalent myopic refractive error between -0.50 to -5.00 D in each eye and astigmatism < 1.00 D
4) Best corrected logMAR visual acuity of 0.1 or better in both eyes
5) Good ocular and general health
6) No previous use of myopia control interventions for more than 1 month or within the last 30 days
7) Competent enough in English to be able to fully understand the participant information and consent form
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Strabismus at distance or near, amblyopia or significant anisometropia (>1D)
2) Systemic or ocular conditions that may affect contact lens use (e.g., allergy) or that may affect refractive development (e.g., ptosis)
3) Previous history of ocular surgery, trauma, or chronic ocular disease
4) Contraindications to contact lens use
5) Ocular or systemic medication use which may interfere or interact with contact lens wear or ocular development
6) Plans to migrate or move during the study
7) Child, parents or guardians not willing to comply with treatment and/or follow-up schedule

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

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
72 participants will be recruited assuming a 20% drop out rate.. A total of 60 participants provides 80% power to reject the null hypothesis that ACUVUE OASYS for PRESBYOPIA is inferior to MiSight at a 0.05 level of significance, assuming a treatment difference of 0.0 mm, a standard deviation of 0.12 mm and a noninferiority margin of 0.05 mm.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/02/2021
Actual
25/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 29131 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 296204 0
Commercial sector/Industry
Name [1] 296204 0
Johnson and Johnson Vision Care, INC
Country [1] 296204 0
United States of America
Primary sponsor type
University
Name
UNSW Sydney
Address
School of Optometry and Vision Science
UNSW Sydney
Gate 14, Barker St
Rupert Myers building (North Wing)
Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 305138 0
None
Name [1] 305138 0
Address [1] 305138 0
Country [1] 305138 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297443 0
UNSW Sydney Human Research Ethics Committee
Ethics committee address [1] 297443 0
Ethics committee country [1] 297443 0
Australia
Date submitted for ethics approval [1] 297443 0
02/02/2020
Approval date [1] 297443 0
05/05/2020
Ethics approval number [1] 297443 0
HC200052

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

Contacts
Principal investigator
Name 74054 0
Prof Isabelle Jalbert
Address 74054 0
School of Optometry and Vision Science
UNSW Sydney
Gate 14, Barker St
Rupert Myers building (North Wing)
Sydney, NSW, 2052
Country 74054 0
Australia
Phone 74054 0
+61290657692
Fax 74054 0
Email 74054 0
i.jalbert@unsw.edu.au
Contact person for public queries
Name 74055 0
Isabelle Jalbert
Address 74055 0
School of Optometry and Vision Science
UNSW Sydney
Gate 14, Barker St
Rupert Myers building (North Wing)
Sydney, NSW, 2052
Country 74055 0
Australia
Phone 74055 0
+61290657692
Fax 74055 0
Email 74055 0
i.jalbert@unsw.edu.au
Contact person for scientific queries
Name 74056 0
Isabelle Jalbert
Address 74056 0
School of Optometry and Vision Science
UNSW Sydney
Gate 14, Barker St
Rupert Myers building (North Wing)
Sydney, NSW, 2052
Country 74056 0
Australia
Phone 74056 0
+61290657692
Fax 74056 0
Email 74056 0
i.jalbert@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.