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

NCT ID: NCT06887920

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-11

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myopia Progressing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non-inferiority, contralateral eye, randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type OTHER

Acuvue Oasys for Presbyopia

Intervention Type 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.

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

Group Type OTHER

MiSight 1 Day

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role collaborator

Pauline Kang

OTHER

Sponsor Role lead

Responsible Party

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Pauline Kang

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of New South Wales

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 40228855 (View on PubMed)

Other Identifiers

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HC200052

Identifier Type: -

Identifier Source: org_study_id

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