NCT06781931

DG1 Spectacle Lens for Myopia Progression Control in Children

DG1 Spectacle Lens for Myopia Progression Control in Children: A Three-year Multicenter, Prospective, Randomized, Double-masked, Controlled Clinical Trial to Evaluate the Efficacy and Safety Followed by a One-year Rebound Evaluation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: HOYA Lens Thailand LTD. · Industry
• Sex: All
• Age: 7 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of the DG1 spectacle lens for myopia progression control in children. * To assess if the DG1 lens will slow the progression of myopia through an adjusted mean difference (e.g., age and baseline SER) of approximately 0.75D in cycloplegic spherical equivalent autorefraction refractive error compared to single-vision (SV) spectacles over the study period. * To assess if DG1 lens will slow the progression of myopia through an adjusted mean difference (e.g., age and baseline SER) of approximately 0.3mm in axial elongation compared to SV over the study period. The clinical trial will compare DG1 spectacle lens to single vision spectacle lens. Participants will wear spectacle lenses and return for visits at regularly scheduled intervals through a 36-month follow up visit. All subjects who complete the 36-month visit will continue in the study for an additional 12 months for the rebound evaluation.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	DG1 Spectacle Lens	DG1 spectacle lens, daily wear for 36 months
DEVICE	Single Vision Spectacle Lens	Single vision spectacle lens, daily wear for 36 months

Timeline

• Start date: 2025-01-21
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2025-01-17
• Last updated: 2025-06-24

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study