Myopia ProgressingMALCOLMNCT06887920
Comparison of MiSight 1-Day and Acuvue Oasys for Presbyopia in Myopic Children
A study testing Acuvue Oasys for Presbyopia and MiSight 1 Day in people with Myopia Progressing, run by Pauline Kang at 1 site in Australia.
Trial summary
This study will compare the effects on myopia progression over the course of one year for eyes wearing MiSight 1 Day contact lenses compared to ACUVUE OASYS for PRESBYOPIA contact lenses. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia Progressing
- What is being tested?
- Acuvue Oasys for Presbyopia and MiSight 1 Day
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Feb 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 6-12 years (inclusive)
- Is willing to wear soft contact lenses daily
- Spherical equivalent myopic refractive error between -0.50 to -5.00 D in each eye and astigmatism < 1.00 D
- Best corrected logMAR visual acuity of 0.1 or better in both eyes
- Good ocular and general health
- No previous use of myopia control interventions for more than 1 month or within the last 30 days
- Competent enough in English to be able to fully understand the participant information and consent form
Who cannot join
- Strabismus at distance or near, amblyopia or significant anisometropia (>1D)
- Systemic or ocular conditions that may affect contact lens use (e.g., allergy) or that may affect refractive development (e.g., ptosis)
- Previous history of ocular surgery, trauma, or chronic ocular disease
- Contraindications to contact lens use
- Ocular or systemic medication use which may interfere or interact with contact lens wear or ocular development
- Plans to migrate or move during the study
- Child, parents or guardians not willing to comply with treatment and/or follow-up schedule
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MultifocAL COntact Lenses for Myopia and Their Effect on Axial Length Elongation in Children
This study will compare the effects on myopia progression over the course of one year for eyes wearing MiSight 1 Day contact lenses compared to ACUVUE OASYS for PRESBYOPIA contact lenses.
- Conditions
- Myopia Progressing
- Being tested
- Acuvue Oasys for Presbyopia, MiSight 1 Day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acuvue Oasys for PresbyopiaDevice
ACUVUE OASYS for PRESBYOPIA contact lenses will be prescribed to children with myopia to be worn in one eye for 10 hours a day for one year.
MiSight 1 DayDevice
MiSight 1 Day contact lenses will be prescribed to children with myopia to be worn in one eye for 10 hours a day for one year.
| Study group | Role | What they receive |
|---|---|---|
| Acuvue Oasys for Presbyopia in the RIGHT eye | Other | Acuvue Oasys for Presbyopia in the RIGHT eye and MiSight 1-Day contact lens in the LEFT eye RIGHT eye has intervention, LEFT eye has active comparator Receives: Device: Acuvue Oasys for Presbyopia |
| MiSight 1-Day in the RIGHT eye | Other | MiSight 1-Day contact lens in the RIGHT eye and Acuvue Oasys for Presbyopia in the LEFT eye RIGHT eye has active comparator, LEFT eye has intervention Receives: Device: MiSight 1 Day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length progression
Change in Axial Length between two eyes measured by laser interferometry (IOL Master)
Measured: 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants.
Cycloplegic autorefraction
Change in Autorefraction between two eyes as measured by autorefractor
Measured: 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants.
Secondary outcomes (6)
Subjective refraction
Change in subjective refraction between two eyes using phoropter or trial frame
Measured: 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants.
Estimates of outdoor time and near work
Estimates of time spent outdoors and on near work with study specific questionnaire. Duration will be reported in minutes or hours.
Measured: 1-month, 6-month and 12-month study visits. Also 3-month and 9-month telehealth visits. 3-month visit was changed to telehealth and 9-month visit added after already enrolling 9 participants.
Quality of Life (PREP2)
Quality of Life measured using the PREP2 survey. Scores are derived from a scale between 0 to 100, with higher values incating better Quality of Life.
Measured: Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.
Quality of Life (PedEyeQ)
Quality of Life measured using the PedEyeQ survey. Scores are derived from a scale between 0 to 100, with higher values incating better Quality of Life.
Measured: Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.
Treatment adherence (Questions)
Contact lens wear duration will be calculated from study-specific questionnaire conducted at study visits. Duration will be reported as hours per day and days per week.
Measured: 1-month, 6-month and 12-month study visits. Added to initial protocol prior to enrolment commencement.
Treatment adherence (Text-message surveys)
Contact lens wear duration will be calculated from study-specific questionnaire sent via text-message. Duration will be reported as hours per day and days per week.
Measured: Study month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12. 1-month, 6-month and 12-month study visits. Added to initial protocol prior to enrolment commencement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start11 Feb 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myopia ProgressingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority, contralateral eye, randomised controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pauline Kang
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Vision Care, Inc.
- Responsible party
- Sponsor-investigator, Pauline Kang, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887920
- Sponsor's protocol ID
- HC200052
- Acronym
- MALCOLM
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dang R, Hui A, Jalbert I, Kho D, Vi M, Briggs N, Kang P. MultifocAL COntact Lenses for Myopia (MALCOLM) control in Australian children: a study protocol for a double-blind, contralateral eye, non-inferiority, randomised controlled clinical trial. BMJ Open. 2025 Apr 14;15(4):e086173. doi: 10.1136/bmjopen-2024-086173.
PubMed 40228855
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MultifocAL COntact Lenses for Myopia and Their Effect on Axial Length Elongation in Children
- ClinicalTrials.gov ID
- NCT06887920
- Acronym / sponsor ID
- MALCOLM / HC200052
- Conditions
- Myopia Progressing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Pauline KangUniversity, hospital or other
- Collaborators
- Johnson & Johnson Vision Care, Inc.
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effects on myopia progression over the course of one year for eyes wearing MiSight 1 Day contact lenses compared to ACUVUE OASYS for PRESBYOPIA contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Non-inferiority, contralateral eye, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Acuvue Oasys for Presbyopia in the RIGHT eye | Other | Device: Acuvue Oasys for PresbyopiaAcuvue Oasys for Presbyopia in the RIGHT eye and MiSight 1-Day contact lens in the LEFT eye RIGHT eye has intervention, LEFT eye has active comparator |
| MiSight 1-Day in the RIGHT eye | Other | Device: MiSight 1 DayMiSight 1-Day contact lens in the RIGHT eye and Acuvue Oasys for Presbyopia in the LEFT eye RIGHT eye has active comparator, LEFT eye has intervention |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged 6-12 years (inclusive)
- Is willing to wear soft contact lenses daily
- Spherical equivalent myopic refractive error between -0.50 to -5.00 D in each eye and astigmatism < 1.00 D
- Best corrected logMAR visual acuity of 0.1 or better in both eyes
- Good ocular and general health
Key exclusion criteria (7 listed)
- Strabismus at distance or near, amblyopia or significant anisometropia (>1D)
- Systemic or ocular conditions that may affect contact lens use (e.g., allergy) or that may affect refractive development (e.g., ptosis)
- Previous history of ocular surgery, trauma, or chronic ocular disease
- Contraindications to contact lens use
- Ocular or systemic medication use which may interfere or interact with contact lens wear or ocular development
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acuvue Oasys for PresbyopiaACUVUE OASYS for PRESBYOPIA contact lenses will be prescribed to children with myopia to be worn in one eye for 10 hours a day for one year. | Device | Acuvue Oasys for Presbyopia in the RIGHT eye |
| MiSight 1 DayMiSight 1 Day contact lenses will be prescribed to children with myopia to be worn in one eye for 10 hours a day for one year. | Device | MiSight 1-Day in the RIGHT eye |
Primary outcome
Axial length progression
Time frame: 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants.
Change in Axial Length between two eyes measured by laser interferometry (IOL Master)
Cycloplegic autorefraction
Time frame: 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants.
Change in Autorefraction between two eyes as measured by autorefractor
6 secondary outcomes
Subjective refraction
Time frame: 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants.
Estimates of outdoor time and near work
Time frame: 1-month, 6-month and 12-month study visits. Also 3-month and 9-month telehealth visits. 3-month visit was changed to telehealth and 9-month visit added after already enrolling 9 participants.
Quality of Life (PREP2)
Time frame: Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.
Quality of Life (PedEyeQ)
Time frame: Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.
Treatment adherence (Questions)
Time frame: 1-month, 6-month and 12-month study visits. Added to initial protocol prior to enrolment commencement.
Treatment adherence (Text-message surveys)
Time frame: Study month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12. 1-month, 6-month and 12-month study visits. Added to initial protocol prior to enrolment commencement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 40228855Dang R, Hui A, Jalbert I, Kho D, Vi M, Briggs N, Kang P. MultifocAL COntact Lenses for Myopia (MALCOLM) control in Australian children: a study protocol for a double-blind, contralateral eye, non-inferiority, randomised controlled clinical trial. BMJ Open. 2025 Apr 14;15(4):e086173. doi: 10.1136/bmjopen-2024-086173.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acuvue Oasys for Presbyopia and MiSight 1 Day in people with Myopia Progressing, run by Pauline Kang at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length progression (time frame: 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06887920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.