Mahdia

Axial myopia is a form of nearsightedness caused by the eye being too long from front to back, which leads to blurry distance vision. It usually starts in childhood and worsens as the eye continues to grow, potentially resulting in serious eye problems later in life. This research aims to study the safety and possible effectiveness of T10430 eye drops in children with axial myopia to slow or stop this progression and prevent more severe complications. The study is a phase 2 trial including 200 children aged 6 to 11 years with a specific range of nearsightedness. Participants will be randomly assigned to receive one of three different doses of T10430 eye drops or a placebo, with one drop instilled in each eye once daily at 8:00 PM (plus or minus 2 hours) from the first day until the day before the final treatment visit. The treatment period will last up to 56 weeks. The eye drops contain the study drug or a vehicle solution as a control. Throughout the study, safety will be closely monitored by recording any treatment-emergent adverse events from the time participants and their guardians provide consent until about 60 weeks later, which includes a 4-week follow-up after treatment ends. Researchers will assess vision changes, eye pressure, and other eye health indicators to evaluate the drug's effects. Participants will attend scheduled visits for assessments, and their adherence to the treatment will be monitored during the study period.