Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Myopia Clinical Trial

— PROTECT  

Official title:

Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05159765
• Other study ID #: VTI-NVMF-MPC-RCT-001
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2022
• Est. completion date: August 2025

Study information

• Verified date: October 2022
• Source: Visioneering Technologies, Inc
• Contact: Ashley Tuan, OD, PhD
• Phone: 1-844-884-5367
• Email: atuan[@]vtivision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative

Intervention

Device:
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Visioneering Technologies, Inc

Countries where clinical trial is conducted

United States,  Canada,  Hong Kong,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Refractive Error relative to Baseline	Mean change in cycloplegic auto-refraction (D)	Baseline, 12, 24, 36 months
Secondary	Change in Axial Length	Mean change in Axial Length (mm)	Baseline,12, 24, 36 months