NCT05159765

Brief Summary

This is a multi-center, randomized, double-masked clinical trial. All study devices are market approved/cleared in the localities where the study is conducted. Subjects will be randomly assigned to wear NaturalVue Sphere single vision contact lenses (SVCL) or NaturalVue Multifocal (NVMF) soft contact lenses for a total of three years.

Trial Health

58
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
4 countries

8 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 22, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

December 2, 2021

Last Update Submit

September 16, 2025

Conditions

Myopia

Keywords

MyopiaRefractive Error

Outcome Measures

Primary Outcomes (1)

  • Change in Refractive Error relative to Baseline

    Mean change in cycloplegic auto-refraction (D)

    Baseline, 12, 24, 36 months

Secondary Outcomes (1)

  • Change in Axial Length

    Baseline,12, 24, 36 months

Study Arms (2)

Control

PLACEBO COMPARATOR

Contact lens with refractive correction, single vision optic

Device: Single vision contact lenses

Treatment

EXPERIMENTAL

Contact lens with refractive correction, multifocal optic

Device: Multifocal contact lenses

Interventions

Single vision contact lensesDEVICE

Wearing contact lenses during waking hours may alter the progression of myopia

Control
Multifocal contact lensesDEVICE

Wearing contact lenses during waking hours may alter the progression of myopia

Treatment

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male or female, aged 7 to \<13 (inclusive) at the Screening/Baseline examination.
  • Meet the following refractive criteria determined by cycloplegic autorefraction at Screening/Baseline:
  • Spherical Equivalent Refractive Error (SERE): between -0.75 and -5.00 D inclusive.
  • Astigmatism: ≤ -0.75 D
  • Anisometropia: \< 1.000

You may not qualify if:

  • Has previously worn or currently wears rigid or gas permeable contact lenses, including orthokeratology lenses,
  • Appears to exhibit poor personal hygiene, that, in the Investigator's opinion, might prevent safe contact lens wear.
  • Is currently, or within 30 days prior to this study has been, an active participant in another clinical study.
  • Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, multifocal or specialized contact lenses, or ANY other myopia control treatment.
  • The Investigator for any reason considers that it is not in the best interest of the subject to participate in the study, including if the child is not mature enough to independently handle and care for soft contact lenses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Fig Garden Optometry

Fresno, California, 93704, United States

Location

North Suburban Vision Consultants

Deerfield, Illinois, 60015, United States

Location

Cooper Eye Care

New York, New York, 10065, United States

Location

Bellaire Family Eye Care

Bellaire, Texas, 77401, United States

Location

Toronto Eye Care

Toronto, Ontario, M4W 1A5, Canada

Location

University of Waterloo School of Optometry

Waterloo, Ontario, N2L 3G1, Canada

Location

Hong Kong Polytechnic University

Tsim Sha Tsui, Hong Kong

Location

Myopia Specialist Centre

Singapore, Singapore

Location

MeSH Terms

Conditions

MyopiaRefractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Ashley Tuan, OD, PhD

    VTI

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 16, 2021

Study Start

January 22, 2022

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)HK(1)SG(1)US(4)