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DG1 Spectacle Lens for Myopia Progression Control in Children

NCT06781931 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-06-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • HOYA Lens Thailand LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-21
Primary Completion
2030-01-31
Completion
2030-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06781931 on ClinicalTrials.gov