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Clinical Trials in the USA / NCT05159765
Active, not recruiting Not applicable

Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

NCT05159765 · tracked via the Priya Life Science USA tracker
Sponsor
Visioneering Technologies, Inc
Phase
Not applicable
Started
2022-01-22
Last updated
2025-09-22

Condition(s) studied

Myopia

Investigational drug(s) / intervention(s)

Single vision contact lensesMultifocal contact lenses

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

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

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.

Eligibility

Sex
ALL
Min age
7 Years
Max age
13 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Change in Refractive Error relative to Baseline — Baseline, 12, 24, 36 months
    Mean change in cycloplegic auto-refraction (D)

Trial sites (8)

FacilityCityRegionStatus
Fig Garden Optometry Fresno California
North Suburban Vision Consultants Deerfield Illinois
Cooper Eye Care New York New York
Bellaire Family Eye Care Bellaire Texas
Toronto Eye Care Toronto Ontario
University of Waterloo School of Optometry Waterloo Ontario
Hong Kong Polytechnic University Tsim Sha Tsui Hong Kong
Myopia Specialist Centre Singapore Singapore

More Visioneering Technologies, Inc trials in the USA

Visual Performance of Center Distance Daily Disposable Multifocal Lenses Active, not recruiting

Other trials for the same condition

MiSight 1 Day Safety Post-Approval Study Active, not recruiting
Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses Recruiting
CYPRESS Efficacy and Safety Study Extension Active, not recruiting
Visual Performance of Center Distance Daily Disposable Multifocal Lenses Active, not recruiting
Myopia Control Spectacle Lens Cessation Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05159765 on ClinicalTrials.gov ↗ ← All trials in the USA