NCT05886348

The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: HOYA Lens Thailand LTD. · Industry
• Sex: All
• Age: 7 Years – 13 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to test Novel spectacle lenses in myopic children. The main question it aims to answer are: safety and efficacy of the lenses. Participants will be asked to wear spectacles and participate in eye exams and questionnaires. Researchers will compare Novel spectacle lenses and general single vision spectacle lenses to see if the Novel spectacle lenses correct myopic ametropia, slow the progression of myopia and axial elongation.

Detailed description

This is a 3-year prospective, multicenter, randomized, and single-masked\*, parallel-group controlled clinical study. The purpose of this study is to evaluate the safety and efficacy of wearing Novel spectacle lenses to correct myopic ametropia, slow the progression of myopia and axial elongation in myopic children as compared to the use of single vision spectacles lenses. The treatment arms are: * Model A Novel spectacle lens * Model B Novel spectacle lens * Single vision spectacle lens Single-masked: The investigator responsible for conducting ocular data measurements related to the primary and secondary endpoints will be masked. The participants will not be informed the treatment arm during the clinical trial.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Model-A Novel spectacle lens	Model-A Novel spectacle lenses will be given to 1 arm to wear for 36 months
DEVICE	Model-B Novel spectacle lens	Model-B Novel spectacle lenses will be given to 1 arm to wear for 36 months
DEVICE	Single vision spectacle lens	Single Vision Spectacle lenses will be given to 1 arm to wear for 36 months

Timeline

• Start date: 2023-07-31
• Primary completion: 2026-05-31
• Completion: 2027-05-31
• First posted: 2023-06-02
• Last updated: 2026-03-23

Locations

5 sites across 1 country: China