Study of Bausch Lomb Myopia Control Lens to Correct Myopic Ametropia and Slow Myopia Progression in Children Aged 8 to 12 Years

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the Bausch Lomb Myopia Control Lens in correcting myopia nearsightedness and slowing its progression in children aged 8 to 12 years. The study is a multi-center, randomized, parallel, bilateral, investigator-masked trial comparing this new lens to an active comparator lens, the CooperVision MiSight, to better understand options for managing myopia in this age group. Participants will be randomly assigned to wear either the Bausch Lomb Myopia Control Soft Hydrophilic lens or the CooperVision MiSight one-day soft contact lens. Both interventions are designed for controlling myopia progression. The study involves wearing the assigned lenses daily for a minimum of 10 hours at least six days per week over a 24-month period. The trial is conducted with masking to reduce bias and ensure objective assessment. Children enrolled in the study will undergo various eye tests including measurements of axial length and spherical equivalent refractive error at baseline and after 1 and 2 years to track changes. Researchers will also monitor visual acuity and eye health throughout the study. The total participation duration is 24 months, with scheduled visits for evaluations and safety monitoring to assess the lenses impact on myopia progression and eye health.

A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children