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

Myopia, or shortsightedness, is a multifactorial disorder, governed by environmental and genetic factors. Myopia is the most common ocular disorder worldwide with an increasing prevalence over the past few decades and affecting the quality of life and economic health of individuals worsening socio-economic problems. Progressive myopia is nearly exclusively a condition of childhood and adolescence, as in most young adults, myopia has stabilized. Myopia frequently appears in childhood, with a peak incidence occurring between 8 and 10 years of age. The most used topical pharmacological intervention for managing childhood myopia progression is atropine, a non-selective muscarinic antagonist, which has been widely used in clinical trials in concentrations ranging from 0.01% to 1.0%. Atropine is at present the agent with the highest efficacy and optimal safety profile to reduce myopia progression in children and adolescents. MODERATO study, a phase III, prospective, multicentric, randomized, double blind, multiple doses, placebo-controlled parallel-group, adaptive study, aims to evaluate the efficacy and safety of 0.025% and 0.05% atropine eye drops in children and adolescents aged 3 to under 18 years old over a 24-month period, to understand its ability to manage and stop myopia getting worse. It will be conducted in 11 centers in Italy, Spain, Poland, the UK and Albania.

NCT Number	NCT07028827
Lead Sponsor	Ocus Innovation Ireland Limited Collaborators: Euromed Pharma Services SRL, Consorzio per Valutazioni Biologiche e Farmacologiche
Conditions	Myopia
Enrollment	234 participants
Start Date	2025-09-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-11