NCT05331378

Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

A Double-masked, Randomized, 2-armed Comparative Study of a Myopia Control Lens (Test Lens) Versus Single Vision Lens (Control Lens).

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Essilor International · Industry
• Sex: All
• Age: 8 Years – 13 Years
• Healthy volunteers: Accepted

Summary

This is a monocenter, randomized, controlled, parallel-group, double-masked clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation at baseline compared to a single vision spectacle lens (control). A total of 80 children will be recruited where 40 subjects will be allocated either to wear test lenses (group 1) or control lenses (group 2) for 1 year through randomization.

Detailed description

As myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. Spectacle lenses with aspherical lenslets were shown to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial. A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy. This double masked parallel group study will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. The study population includes children in Singapore aged 8 to 13 years (80 subjects) at the time of commencing treatment. As age of myopia onset is known to be an important factor in rate of myopia progression, subject age at the time of enrollment will be used to balance randomization. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuity will also be compared between test lenses and control lenses to determine the quality of vision using test lenses.

Conditions

• Myopia, Progressive
• Myopia

Interventions

Type	Name	Description
DEVICE	Test myopia control lenses	A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.
DEVICE	Single vision lenses	A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.

Timeline

• Start date: 2022-04-25
• Primary completion: 2024-10-29
• Completion: 2025-10-01
• First posted: 2022-04-15
• Last updated: 2025-08-07

Locations

1 site across 1 country: Singapore