NCT06850168

Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Essilor International · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is: Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children? Researchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression. Participants will: * Wear the study spectacles * Visit Essilor R\&D Centre for follow-up sessions

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	SVL	Dispensed to one eye in Year 1
DEVICE	SVL with passive red-light emission	Dispensed to the contralateral eye in Year 1.
DEVICE	MCL	Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).
DEVICE	MCL with passive red-light emission	Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).

Timeline

• Start date: 2025-06-26
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2025-02-27
• Last updated: 2025-08-07

Locations

1 site across 1 country: Singapore