Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Last updated: October 3, 2022
Sponsor: Visioneering Technologies, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

N/A

Clinical Study ID

NCT05159765
VTI-NVMF-MPC-RCT-001
  • Ages 7-13
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

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 atScreening/Baseline:
  • Spherical Equivalent Refractive Error (SERE): between -0.75 and -5.00 Dinclusive.
  • Astigmatism: ≤ -0.75 D
  • Anisometropia: < 1.000

Exclusion

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, mightprevent safe contact lens wear.
  3. Is currently, or within 30 days prior to this study has been, an active participant inanother 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 thesubject to participate in the study, including if the child is not mature enough toindependently handle and care for soft contact lenses.

Study Design

Total Participants: 144
Study Start date:
January 22, 2022
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Toronto Eye Care

    Toronto, Ontario M4W 1A5
    Canada

    Active - Recruiting

  • University of Waterloo School of Optometry

    Waterloo, Ontario N2L 3G1
    Canada

    Active - Recruiting

  • Hong Kong Polytechnic University

    Tsim Sha Tsui,
    Hong Kong

    Active - Recruiting

  • Myopia Specialist Centre

    Singapore,
    Singapore

    Active - Recruiting

  • Fig Garden Optometry

    Fresno, California 93704
    United States

    Active - Recruiting

  • North Suburban Vision Consultants

    Deerfield, Illinois 60015
    United States

    Active - Recruiting

  • Cooper Eye Care

    New York, New York 10065
    United States

    Active - Recruiting

  • Bellaire Family Eye Care

    Bellaire, Texas 77401
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.