MedTrace Logo

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

NCT06034327 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • SightGlass Vision, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2027-01-31
Completion
2027-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06034327 on ClinicalTrials.gov