Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2025

Interventions

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

Arms, Groups and Cohorts

  • Placebo Comparator: Control
    • Contact lens with refractive correction, single vision optic
  • Experimental: Treatment
    • Contact lens with refractive correction, multifocal optic

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change in Axial Length
    • Time Frame: Baseline,12, 24, 36 months
    • Mean change in Axial Length (mm)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 13 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Visioneering Technologies, Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ashley Tuan, OD, PhD, Study Chair, VTI
  • Overall Contact(s)
    • Ashley Tuan, OD, PhD, 1-844-884-5367, atuan@vtivision.com

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