Phase 3 Study to Evaluate Safety and Efficacy of QLM3004 Eye Drops in Slowing Myopia Progression in Children

What this Trial Is About

Researchers are studying QLM3004, an eye drop medication, to see if it can slow down the worsening of myopia (nearsightedness) in children aged 6 to 12 years. This Phase 3 clinical trial compares three different doses of QLM3004 against a placebo over a treatment period of 96 weeks. The study includes two phases: the first focuses on confirming safety and effectiveness, and the second is an observation period after stopping the treatment, which does not affect the study's main results. Participants receive one of four treatments: low, medium, or high doses of QLM3004 eye drops or a placebo solution. Each dose is applied as one drop in each eye at bedtime daily during the 96-week treatment phase. After treatment ends, children enter a follow-up observation period to monitor their condition without receiving the study medication. During the study, children will have their vision tested regularly using cycloplegic autorefraction to measure changes in their spherical equivalent, which reflects the degree of myopia. Researchers will evaluate safety and monitor any side effects throughout the treatment and observation phases. Participation involves regular visits for assessments over nearly two years to track how the medication affects myopia progression and eye health.

A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children