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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05159765
Other study ID # VTI-NVMF-MPC-RCT-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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