CClinicalTrials.gg
Active, not recruitingNCT05159765PROTECTUpdated Sep 22, 2025

Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

An interventional study of Single vision contact lenses and Multifocal contact lenses in Myopia, sponsored by Visioneering Technologies, Inc. Active, not recruiting at 8 sites in 4 countries. Open to participants aged 7 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Visioneering Technologies, Inc · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
7 Years to 13 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myopia

Keywords

  • Myopia
  • Refractive Error
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 144 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Visioneering Technologies, Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male or female, aged 7 to \<13 (inclusive) at the Screening/Baseline examination.
  2. 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

Exclusion criteria

Exclusion Criteria:

  1. Has previously worn or currently wears rigid or gas permeable contact lenses, including orthokeratology lenses,
  2. Appears to exhibit poor personal hygiene, that, in the Investigator's opinion, might prevent safe contact lens wear.
  3. Is currently, or within 30 days prior to this study has been, an active participant in another clinical study.
  4. Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, multifocal or specialized contact lenses, or ANY other myopia control treatment.
  5. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
144 participants (estimated)

Study arms

  • Placebo comparator
    Control

    Contact lens with refractive correction, single vision optic

    Device: Single vision contact lenses

  • Experimental
    Treatment

    Contact lens with refractive correction, multifocal optic

    Device: Multifocal contact lenses

Interventions

  • DeviceSingle vision contact lenses

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

  • DeviceMultifocal contact lenses

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

06

What researchers measure

Primary outcomes

  1. Change in Refractive Error relative to Baseline

    Mean change in cycloplegic auto-refraction (D)

    Time frame: Baseline, 12, 24, 36 months

Secondary outcomes

  1. Change in Axial Length

    Mean change in Axial Length (mm)

    Time frame: Baseline,12, 24, 36 months

07

Study locations

8 sites
  • Fig Garden Optometry
    Fresno, California 93704, United States
  • North Suburban Vision Consultants
    Deerfield, Illinois 60015, United States
  • Cooper Eye Care
    New York, New York 10065, United States
  • Bellaire Family Eye Care
    Bellaire, Texas 77401, United States
  • Toronto Eye Care
    Toronto, Ontario M4W 1A5, Canada
  • University of Waterloo School of Optometry
    Waterloo, Ontario N2L 3G1, Canada
  • Hong Kong Polytechnic University
    Tsim Sha Tsui, Hong Kong
  • Myopia Specialist Centre
    Singapore, Singapore
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05159765
Lead sponsor
Visioneering Technologies, Inc
Responsible party
Sponsor
First posted
Dec 16, 2021
Start date
Jan 22, 2022
Primary completion
Feb 2026 (estimated)
Completion
Feb 2026 (estimated)
Last update
Sep 22, 2025

Study contacts

Ashley Tuan, OD, PhD
study chair · VTI

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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