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

Summary

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.

Conditions

• Myopia

Interventions

DRUG

0.05% atropine eye drops

One drop of 0.05% atropine in each eye once a day before bedtime

DRUG

0.025% atropine eye drops

One drop of 0.025% atropine in each eye once a day before bedtime

DRUG

placebo eye drops

One drop of placebo in each eye once a day before bedtime

Sponsors & Collaborators

• Euromed Pharma Services SRL

  collaborator INDUSTRY

• Consorzio per Valutazioni Biologiche e Farmacologiche

  collaborator OTHER

• Ocus Innovation Ireland Limited

  lead INDUSTRY

Principal Investigators

• Ian CK Wong, Professor · Ocus Innovation Ireland Limited

• Annegret Dahlmann-Noor, PhD · NIHR Moorfields Biomedical Research Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Albania
• Italy
• Poland
• Spain
• United Kingdom

Study Locations