Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial (PROTECT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Single vision contact lenses; Device: Multifocal contact lenses

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Contact lens with refractive correction, single vision optic	Device: Single vision contact lenses; Wearing contact lenses during waking hours may alter the progression of myopia
Experimental: Treatment; Contact lens with refractive correction, multifocal optic	Device: Multifocal contact lenses; Wearing contact lenses during waking hours may alter the progression of myopia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Refractive Error relative to Baseline	Mean change in cycloplegic auto-refraction (D)	Baseline, 12, 24, 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Axial Length	Mean change in Axial Length (mm)	Baseline,12, 24, 36 months

Collaborators and Investigators

• Sponsor: Visioneering Technologies, Inc
• Investigators: Study Chair: Ashley Tuan, OD, PhD, VTI

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2022
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Myopia; Refractive Error
• Additional Relevant MeSH Terms: Eye Diseases; Myopia; Refractive Errors
• Other Study ID Numbers: VTI-NVMF-MPC-RCT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No