NCT07535749

Brief Summary

The study will employ a randomized, controlled, investigator-masked paired-eye comparison design to evaluate the effects of two myopia-control contact lenses-MiSight 1 Day and Abiliti 1-Day-in New Zealand Chinese children. The study duration will be 6 months, with assessments conducted at baseline, 2 weeks, 3 months, and 6 months. The clinical research will be conducted at the Auckland Myopia Clinic (New Zealand) and will follow a standard clinical routine for children with early myopia, the only difference being the randomizing of the MiSight and Abiliti contact lenses between the two eyes of the participants.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
7mo left

Started Mar 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 21, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

March 24, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

myopia controlcontact lenses

Outcome Measures

Primary Outcomes (2)

  • Mean Spherical Equivalent Cycloplegic Refraction

    The dioptric refractive error as determined by retinoscopy following cycloplegic refraction

    Baseline, 2 weeks, 3 months, 6 months

  • Axial length

    Ocular biometry measured with Myah biometer

    Baseline, 2 weeks, 3 months, 6 months

Secondary Outcomes (5)

  • Children Dry Eye Questionnaire (CDEQ) response

    Baseline, 2 weeks, 3 months, 6 months

  • Non-invasive Tear break-up time

    Baseline, 2 weeks, 3 months, 6 months

  • Ocular Protection Index

    Baseline, 2 weeks, 3 months, 6 months

  • Corneal punctate spots

    Baseline, 2 weeks, 3 months, 6 months

  • Conjunctival punctate spots

    Baseline, 2 weeks, 3 months, 6 months

Study Arms (2)

MiSight Contact Lens

ACTIVE COMPARATOR

Commercially available myopia control contact lens

Device: MiSight Contact Lenses (CooperVision)

Abiliti 1-Day

ACTIVE COMPARATOR

Commercially available myopia control contact lens

Device: Albiliti 1-Day (Johnson and Johnson, VisionCare)

Interventions

Myopia Control Contact Lens

MiSight Contact Lens

Myopia Control Contact Lens

Abiliti 1-Day

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Spherical refractive error between -1.00D and -4.50D
  • Astigmatism of ≤1.00D
  • No history of orthokeratology or atropine use
  • No ocular diseases or surgical history

You may not qualify if:

  • o No ocular diseases or surgical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auckland Myopia Clinic

Auckland, 1052, New Zealand

RECRUITING

Central Study Contacts

James S Wolffsohn, BSc PhD DSc

CONTACT

Vivienne Wang, BSc

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Contralateral eye study, randomised
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

April 17, 2026

Study Start

March 21, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Patients have not given permission for this

Locations