Phase III Study of Low-Dose Atropine Eye Drops to Slow Myopia Progression in Children and Adolescents Aged 3 to Under 18 Years

What this Trial Is About

Myopia, commonly known as shortsightedness, is a condition influenced by both genetic and environmental factors. It is the most widespread eye disorder globally, with increasing cases especially among children and adolescents, where it tends to worsen. This study, called the MODERATO study, is a phase III clinical trial designed to evaluate how well low-dose atropine eye drops 0.025% and 0.05% work in slowing down myopia progression in children and adolescents aged 3 to under 18 years, compared with placebo, over a 24-month period. Participants will be randomly assigned to one of three groups one receiving 0.05% atropine eye drops, another receiving 0.025% atropine eye drops, and the third receiving placebo eye drops. Each participant will instill one drop in each eye once daily before bedtime. The study includes an adaptive design with an early escape phase at six months, where participants showing worsening myopia on placebo may switch to active treatment, and a planned interim analysis after one year to assess treatment effectiveness and adjust the study as needed. During the study, participants will undergo various eye examinations including refraction tests, pupil diameter measurements, accommodation amplitude, intraocular pressure, stereopsis, slit lamp and macularoptic disc examinations, and ocular biometry. Questionnaires assessing vision-related quality of life and treatment acceptability will also be completed. Safety monitoring will be ongoing, and no follow-up visits are planned after the study ends. The main outcome measured is the mean annual rate of myopia progression over 24 months.

Atropine Eyedrops for Myopia Progression in Children and Adolescents (MODERATO STUDY)