NCT06034327

Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: SightGlass Vision, Inc. · Industry
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Accepted

Summary

This is a conventional efficacy trial to validate the results from previous clinical trials for younger children; the 12-month efficacy results will be used to predict the 3-year treatment efficacy. This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.

Conditions

• Myopia
• Juvenile Myopia
• Myopia Progression

Interventions

Type	Name	Description
DEVICE	Single vision, impact-resistant spectacle lenses; Test Arm	Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia
DEVICE	Single vision, impact-resistant spectacle lenses; Control Arm	Single vision, impact-resistant spectacle lenses

Timeline

• Start date: 2023-09-18
• Primary completion: 2027-01-31
• Completion: 2027-03-31
• First posted: 2023-09-13
• Last updated: 2025-12-29

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study