RECRUITING

Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Description

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.

Conditions

Myopia
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Related Conditions:

Myopia

Study Overview

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Study Details

Study 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.

Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Condition
Myopia
Intervention / Treatment

-

Contacts and Locations

Fresno

Fig Garden Optometry, Fresno, California, United States, 93704

Deerfield

North Suburban Vision Consultants, Deerfield, Illinois, United States, 60015

New York

Cooper Eye Care, New York, New York, United States, 10065

Bellaire

Bellaire Family Eye Care, Bellaire, Texas, United States, 77401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

7 Years to 13 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Visioneering Technologies, Inc,

Ashley Tuan, OD, PhD, STUDY_CHAIR, VTI

Study Record Dates

2025-08