Low-dose atropine eye drops to slow myopia in children and adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

MODERATO is a phase III, randomized, double-blind, placebo-controlled, multicenter trial comparing two low concentrations of atropine eye drops (0.025% and 0.05%) against placebo. About 234 participants aged 3 to under 18 with bilateral myopia (spherical equivalent ≤ -0.75 D) will be randomized 1:1:1 across 11 centers in Italy, Spain, Poland, the UK, and Albania. The primary outcome is change in myopia progression over 24 months with a planned interim efficacy analysis after 50% of participants complete one year. An "early escape" option is included for placebo recipients showing significant worsening at six months.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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
• Children's Memorial Health Institute, Department of Ophthalmology
  Warsaw, Poland Recruiting
• Hospital Universitario Parc Taulí
  Barcelona, Spain Recruiting
• Hospital Puerta del Mar (INIBICA)
  Cadiz, Spain Recruiting

Study contacts

• Principal investigator: Ian CK Wong, Professor — Ocus Innovation Ireland Limited
• Study coordinator: Irisi Sukaj
• Email: isukaj@cvbf.net
• Phone: +355 68 90 37 854

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.