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

NCT06887920 | Active Not Recruiting FDA Device

• 1 other identifier: HC200052
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia Progressing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Subjective refraction

  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

  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)

  Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.

• Quality of Life (PedEyeQ)

  Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.

• Treatment adherence (Questions)

  1-month, 6-month and 12-month study visits. Added to initial protocol prior to enrolment commencement.

Other Outcomes (8)

• Corneal topography

  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

  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

  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.

Study Arms (2)

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

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

Device: MiSight 1 Day

Interventions

Acuvue Oasys for Presbyopia DEVICE

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.

Acuvue Oasys for Presbyopia in the RIGHT eye

MiSight 1 Day DEVICE

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.

MiSight 1-Day in the RIGHT eye

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pauline Kang: lead
• Johnson & Johnson Vision Care, Inc.: collaborator

Study Sites (1)

University of New South Wales

Sydney, New South Wales, 2052, Australia

Location

Related Publications (1)

• 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.

  PMID: 40228855 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Non-inferiority, contralateral eye, randomised controlled trial

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 21, 2025
• Study Start: February 11, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)