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

Pauline Kang

Status: Active, not recruiting

Conditions: Myopia Progressing

Treatments: Device: Acuvue Oasys for Presbyopia; Device: MiSight 1 Day

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06887920

HC200052

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

72 participants in 2 patient groups

Acuvue Oasys for Presbyopia in the RIGHT eye

Other group

Description:

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

Treatment:

Device: Acuvue Oasys for Presbyopia

MiSight 1-Day in the RIGHT eye

Other group

Description:

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

Treatment:

Device: MiSight 1 Day