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

NCT07028827 | Recruiting Phase 3 DMC

• 4 other identifiers: OCUS-Mode-CT-V12023-510439-13-001009562U1111-1304-3811
• Study Type: interventional
• Target: 234
• Locations: 5 countries
• Sites: 11

Brief 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

Keywords

Myopia; Atropine sulfate; Eye drops; Short-sightedness; Eye Diseases; Paediatric population

Outcome Measures

Primary Outcomes (1)

• Mean annual rate of progression of myopia

  The primary outcome measure evaluates the efficacy of atropine in slowing myopia progression in children and adolescents. The mean annual rate of progression of myopia (D/year) based on spherical equivalent (SE) measured by cycloplegic autorefraction over 24 months.

  24 months

Secondary Outcomes (12)

• Number and percentage of early escape patients.

  6 months

• Mean change in axial length and glasses prescription.

  3, 6, 12, 18 and 24 months

• Safety assessment of atropine.

  3, 6, 12, 18 and 24 months

• Use of photochromic and/or varifocal lenses.

  3, 6, 12, 18, and 24 months

• Changes in photosensitivity index.

  Baseline, 3, 6, 12, 18, and 24 months

Study Arms (3)

Group 1

EXPERIMENTAL

This group (N = 78 subjects) will be treated with 0.05% atropine eye drops

Drug: 0.05% atropine eye drops

Group 2

EXPERIMENTAL

This group (N = 78 subjects) will be treated with 0.025% atropine eye drops

Drug: 0.025% atropine eye drops

Group 3

PLACEBO COMPARATOR

This group (N = 78 subjects) will be treated with placebo eye drops

Drug: placebo eye drops

Interventions

0.05% atropine eye drops DRUG

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

Also known as: atropine sulfate eye drops solutions (0.05%)

Group 1

0.025% atropine eye drops DRUG

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

Also known as: atropine sulfate eye drops solutions (0.025%)

Group 2

placebo eye drops DRUG

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

Also known as: Control

Group 3

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males and females, aged from 3 to less than 18 years.
• Subjects showing myopia with a spherical equivalent refraction of both eyes at least -0.75 D at baseline.
• The intraocular pressure in each eye must be equal or less than 21 mmHg.
• The parents or the legal representative must be informed about the clinical trial and must sign the informed consent form. The exception to consider is related to the individuals aged above 16 years only in the UK, who can provide their own consent according to the local regulations.
• Women with childbearing potential (WOCBP) (after menarche) who have a negative highly sensitive urine dipstick pregnancy test. Additional pregnancy testing during the study will be conducted at visits 1, 2, 3, 4, 5, 6.
• WOCBP or males who are using a highly effective birth control method to prevent pregnancies. Eligible highly effective contraceptive methods for WOCBP are combined (which contain estrogen and progestogen) hormonal contraception associated with inhibition of ovulation (oral, intravaginal (inside of the vagina), transdermal (through the skin)); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (small devices that are placed inside uterus to prevent pregnancies); intrauterine hormone-releasing system. Sexual abstinence represents a highly effective contraceptive method, if in line with the subject's normal habits.

You may not qualify if:

• Anisometropia, meaning a significant difference in refractive power between the two eyes exceeding \|1.5\| D.
• Refractive astigmatism exceeding \|1.5\| D.
• Presence of ocular pathologies such as pathological myopia, corneal scars, or other anterior or posterior eye pathologies.
• History of amblyopia or strabismus.
• Presence of a history of a retinal dystrophy or systemic disorder that may predispose to severe myopia (e.g., Marfan syndrome, retinitis pigmentosa, Stickler syndrome, retinopathy of prematurity)
• Abnormalities in ocular biometry, except for axial length or previous intraocular or ocular laser/non-laser surgery.
• History of glaucoma or narrow angles in the anterior chamber of the eye.
• Conditions such as Down syndrome or spastic paralysis.
• Known intolerance or allergies to atropine eye drops or hypersensitivity to any component of the atropine eye drops.
• Pregnancy or breastfeeding.
• History of alcohol or drug abuse.
• Mental or emotional instability that could interfere with study procedures.
• Lack of reliability or cooperation from the patient.
• Other reasons, at the discretion of the investigator that may deem the subject's participation in the study inappropriate.
• Patients who have consented to participate in the clinical trial, but do not meet one or more eligibility criteria required for participation in the trial during the screening procedures, and subsequently are not randomly assigned to the study treatment or entered in the study, are considered screening failures.

Sponsors & Collaborators

• Ocus Innovation Ireland Limited: lead
• Euromed Pharma Services SRL: collaborator
• Consorzio per Valutazioni Biologiche e Farmacologiche: collaborator

Study Sites (11)

University Hospital Centre Mother Teresa (UHCT), Paediatric Department

Tirana, Albania

RECRUITING

Ophthalmology - AOU Consorziale Policlinico - Ospedale Pediatrico Giovanni XXIII

Bari, Italy

RECRUITING

Pediatric Ophthalmology - Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Milan

Milan, Italy

RECRUITING

Azienda Ospedale Università Padova

Padua, Italy

NOT YET RECRUITING

Children's Memorial Health Institute, Department of Ophthalmology

Warsaw, Poland

RECRUITING

Hospital Universitario Parc Taulí

Barcelona, 08208, Spain

RECRUITING

Hospital Puerta del Mar (INIBICA)

Cadiz, 11009, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Northern Ireland Clinical Research Facility. U Floor. Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

RECRUITING

School of Optometry, Aston University

Birmingham, United Kingdom

RECRUITING

R&D, Moorfields Eye Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Myopia; Eye Diseases

Condition Hierarchy (Ancestors)

Refractive Errors

Study Officials

• Ian CK Wong, Professor

  Ocus Innovation Ireland Limited

  PRINCIPAL INVESTIGATOR

• Annegret Dahlmann-Noor, PhD

  NIHR Moorfields Biomedical Research Centre

  STUDY CHAIR

Central Study Contacts

Irisi Sukaj

CONTACT

+355 68 90 37 854; isukaj@cvbf.net

Alessandra Foietta

CONTACT

+39 0382 1475411; afoietta@cvbf.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study is designed as a double blinded clinical trial. During the trial, neither the participants nor the delegated staff will be aware of the group allocation. The 0.025% or 0.05% atropine eye drops and placebo eye drops will be prepared in a manner that will appear similar in appearance. The assignment of groups will not be disclosed to the subjects and the Investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study design includes 2 active arms (Atropine 0.025% or 0.05%) and a placebo arm. The study has a 2 stages seamless adaptive design (before/after interim analysis results). After the interim analysis, when half of the planned sample size is enrolled and the 1-year efficacy evaluation is available, the use of an adaptive trial design will be deemed: * each active arm will be stopped for futility if there are 8 patients or fewer (≤ 22.9%) with response (reduction in mean SE progression of at least 20% when compared with the placebo group; * the placebo arm will be stopped early for evidence of efficacy if there are 27 patients or more (≥ 77.1%) with response (reduction in mean SE progression of at least 20% when compared with the placebo group) in both active arms. Instead, if active arms show a favorable SE change but fewer than 27 responders in 1 or both active arms, an advantage for atropine can be hypothesized, allowing for sample size re-estimation to ensure adequate study power

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); IT (3); ES (3); AL (1); PL (1)