Evaluation of NaturalVue Multifocal Contact Lenses for Myopia Treatment

Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

This study tests if NaturalVue Multifocal contact lenses can help slow down worsening eyesight in children aged 7 to 12 compared to regular single vision lenses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 7 Years to 13 Years
• Sex: All
• Sponsor: Visioneering Technologies, Inc (Industry-sponsored)
• Locations: 8 sites (Fresno, California and 7 other locations)
• Trial ID: NCT05159765 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of NaturalVue Multifocal contact lenses compared to single vision contact lenses in treating progressive myopia in children aged 7 to 12. Participants will be randomly assigned to wear either type of lens for a duration of three years. The study aims to determine if multifocal lenses can better control myopia progression compared to traditional single vision lenses. All devices used in the trial are approved for use in the locations where the study is conducted.

Who should consider this trial

Good fit: Ideal candidates are children aged 7 to 12 with specific refractive errors within the study's inclusion criteria.

Not a fit: Patients who have previously used certain types of contact lenses or myopia control treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for managing progressive myopia in children.

How similar studies have performed: Previous studies have shown promising results with multifocal lenses in managing myopia, suggesting this approach has potential.

Eligibility criteria

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.

Where this trial is running

Fresno, California and 7 other locations

• Fig Garden Optometry — Fresno, California, United States (Recruiting)
• North Suburban Vision Consultants — Deerfield, Illinois, United States (Recruiting)
• Cooper Eye Care — New York, New York, United States (Recruiting)
• Bellaire Family Eye Care — Bellaire, Texas, United States (Recruiting)
• Toronto Eye Care — Toronto, Ontario, Canada (Recruiting)
• University of Waterloo School of Optometry — Waterloo, Ontario, Canada (Recruiting)
• Hong Kong Polytechnic University — Tsim Sha Tsui, Hong Kong (Recruiting)
• Myopia Specialist Centre — Singapore, Singapore (Recruiting)

Study contacts

• Study coordinator: Ashley Tuan, OD, PhD

Conditions Myopia; Refractive Error