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

Launched by OCUS INNOVATION IRELAND LIMITED · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial, called the MODERATO study, is looking at whether low-dose atropine eye drops can help slow down the worsening of myopia (also known as shortsightedness) in children and teenagers. Myopia is a common eye condition where distant objects appear blurry, and it usually starts and progresses during childhood. This study will test two different strengths of atropine eye drops (0.025% and 0.05%) over two years to see how well they work and how safe they are for young people aged 3 to under 18 years old.

Children and teens who have myopia of at least -0.75 diopters (a way to measure how nearsighted someone is) and normal eye pressure may be eligible to join. Participants will use the eye drops regularly and visit the study centers in Europe for check-ups to monitor their eye health and myopia progression. Parents or guardians will give consent for their children to join, while teens over 16 in the UK may consent for themselves. The study excludes those with certain eye problems, other health issues, or previous myopia treatments that could affect the results. This trial aims to find a safe and effective way to help slow down myopia in young people, which could improve their quality of life as they grow.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.