Evaluating Safety and Effectiveness of T10430 Eye Drops to Slow Myopia Progression in Children Aged 6 to 11

What this Trial Is About

Axial myopia is a form of nearsightedness caused by the eye being too long from front to back, leading to blurry distant vision. It typically begins in childhood and worsens as the eyes grow longer, potentially causing serious eye issues later in life. Researchers are studying T10430 eye drops to see if they can slow or stop this progression in children aged 6 to 11 years, aiming to prevent more severe complications. This Phase 2 trial also evaluates the safety of T10430 based on encouraging animal study results. Participants will be randomly assigned to receive one of three different strengths of T10430 eye drops or a placebo. Each participant will instill one drop in each eye once daily at around 8 PM for up to 56 weeks, followed by a 4-week follow-up period. The study will include about 200 children with axial myopia, and the treatments will be given under double-blind conditions so neither participants nor researchers know which dose is administered. Throughout the study, children and their guardians will attend visits for physical and eye examinations to monitor safety and treatment effects. Researchers will measure treatment-emergent adverse events during the entire study period of up to 60 weeks. They will also assess changes in axial eye length and spherical equivalent refraction at 6 and 12 months. This careful monitoring aims to understand how T10430 impacts eye growth and vision while ensuring participant safety.

Safety and Efficacy of T10430 Eye Drops in Controlling Paediatric Myopia Progression