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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Myopia

In brief

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.

Key facts

Study ID

NCT07028827

Run by

Ocus Innovation Ireland Limited

People needed

234

Starts

2025-09-01

Expected to finish

2027-12-31

Last updated by the study team

2026-02-11

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.
• Any treatment received for myopia within the past three months prior to inclusion in the study.
• 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.

Where it is running

• R&D, Moorfields Eye Hospital — London, United Kingdom (enrolling)
• Ophthalmology - AOU Consorziale Policlinico - Ospedale Pediatrico Giovanni XXIII — Bari, Italy (enrolling)
• Pediatric Ophthalmology - Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Milan — Milan, Italy (enrolling)
• University Hospital Centre Mother Teresa (UHCT), Paediatric Department — Tirana, Albania (enrolling)
• Children's Memorial Health Institute, Department of Ophthalmology — Warsaw, Poland (enrolling)
• Hospital Universitario Parc Taulí — Barcelona, Spain (enrolling)
• Hospital Puerta del Mar (INIBICA) — Cadiz, Spain (enrolling)
• Hospital Universitario La Paz — Madrid, Spain (enrolling)
• Northern Ireland Clinical Research Facility. U Floor. Belfast City Hospital — Belfast, United Kingdom (enrolling)
• School of Optometry, Aston University — Birmingham, United Kingdom (enrolling)
• Azienda Ospedale Università Padova — Padua, Italy

Full record on ClinicalTrials.gov

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