Comparison of MiSight 1-Day and Acuvue Oasys for Presbyopia in Myopic Children (MALCOLM)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia Progressing
• Intervention / Treatment: Device: Acuvue Oasys for Presbyopia; Device: MiSight 1 Day

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2052
      • University of New South Wales

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Acuvue Oasys for Presbyopia in the RIGHT eye; 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	Device: Acuvue Oasys for Presbyopia; 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.
Other: MiSight 1-Day in the RIGHT eye; 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	Device: MiSight 1 Day; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length progression	Change in Axial Length between two eyes measured by laser interferometry (IOL Master)	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective refraction	Change in subjective refraction between two eyes using phoropter or trial 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	Estimates of time spent outdoors and on near work with study specific questionnaire. Duration will be reported in minutes or hours.	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.	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.	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.	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.	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal topography	Change in Corneal topography measurements between two eyes as measured by corneal topographer (Oculus Keratograph, Medmont E300)	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.
Amplitude of Accommodation	Change in amplitude of accommodation between the two eyes with push up test	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.
Visual acuity	Change in distance and near vision between the two eyes using visual acuity charts	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.
Anterior Chamber Depth	Change in anterior chamber depth between the two eyes with laser interferometry (IOL Master) and optical coherence tomography (Casia SS-1000)	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.
Corneal radii	Change in corneal radii between the two eyes with laser interferometry (IOL Master).	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.
Lens thickness	Change in lens thickness between the two eyes with laser interferometry (IOL Master).	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.
Posterior segment depth	Change in posterior segment depth measurements with optical coherence tomography	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.
Pupils	Change in pupillary measurements as measured by pupillometer	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.

Collaborators and Investigators

• Sponsor: Pauline Kang
• Collaborators: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: HC200052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes