RecruitingPHASE3INTERVENTIONAL

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

The MODERATO study is looking at short-sightedness, also known as myopia, which is when distant objects appear blurry. This condition often starts in childhood and can get worse over time. Doctors are testing two different strengths of atropine eye drops (0.025% and 0.05%) to see if they can help stop myopia from getting worse in children and teenagers aged 3 to under 18. This is a large study involving many clinics across several countries, comparing the new drops to 'dummy' drops (placebo). The main aim is to find out if these eye drops are effective and safe in slowing down the progression of myopia over two years. An important part of the study is making sure children who don't get the active treatment can switch to it if their vision gets considerably worse.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Ocus Innovation Ireland Limited

Enrolment target

234

Start

01 Sep 2025

Estimated completion

31 Dec 2027

Myopia

What is this study about?

Short-sightedness, also called myopia, is a very common eye condition where distant objects look blurry, while close-up things appear clear. It's becoming more common around the world, especially in children and teenagers. For many young people, their short-sightedness can worsen quite quickly, which can be worrying. This study, called MODERATO, is designed to investigate a treatment that doctors believe could help slow down this worsening.

Atropine eye drops have been used before for this purpose and seem promising. This particular study is a 'Phase 3' trial, which means it’s a big, thorough study to check if two specific, lower strengths of atropine eye drops (0.025% and 0.05%) are both safe and effective. These strengths are being compared against 'dummy' drops (called a placebo) to clearly see the effect of the atropine.

The study involves children and teenagers aged between 3 and 17 years old across different countries, including the UK. Researchers want to observe what happens over two years to understand if these eye drops can truly make a difference in slowing down the progression of short-sightedness. The goal is to find a good way to manage this common vision problem in young people.

Key takeaways

This study tests eye drops to slow down short-sightedness in children.
It compares two strengths of atropine drops to dummy drops.
The study lasts for two years and involves regular eye checks.
Children whose vision worsens on dummy drops will switch to active treatment.
It aims to find safe and effective ways to manage myopia progression.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for children and teenagers aged from 3 up to 17 years old. To join, they need to have short-sightedness where their vision is at least -0.75 in both eyes, and their eye pressure must be normal. If a child is aged 16 or 17 in the UK, they might be able to agree to take part themselves, but for younger children, a parent or legal guardian will need to give permission.

There are also some reasons why someone might not be able to join. For example, if there's a big difference in short-sightedness between their two eyes, or if they have more than -1.5 of astigmatism (another common vision problem). Children with certain other eye conditions or specific medical problems that could affect their eyes are also not able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 3 and 17 years old?
Does your child have short-sightedness of at least -0.75 in both eyes?
Does your child have normal eye pressure?
Does your child NOT have a big difference in vision between their eyes (anisometropia)?
Does your child NOT have other serious eye conditions or specific medical problems affecting their eyes?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will use eye drops (either 0.025% atropine, 0.05% atropine, or dummy drops) every day for two years. Neither you nor the study doctors will know which drops they are receiving. They will have regular check-ups at a clinic – these visits will include eye tests and other assessments to see how their vision is changing and to check for any side effects. These check-ups will happen several times over the two-year period. If, after six months, a child receiving the dummy drops shows their short-sightedness getting significantly worse, they will be switched to receive the active atropine drops. The total duration of the study, including all treatments and follow-up, is 24 months.

Potential risks and benefits

Taking part could offer the potential benefit of slowing down your child's short-sightedness, which might mean their glasses prescription doesn't increase as much. However, like all medicines, atropine drops can have side effects, which might include blurry close-up vision or sensitivity to light. Some children will receive dummy drops and might not get the active treatment straight away. You are free to withdraw your child from the study at any time without giving a reason, and this will not affect their future medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital Centre Mother Teresa (UHCT), Paediatric Department
Verified postcode
Tirana, Albania· Recruiting
Ophthalmology - AOU Consorziale Policlinico - Ospedale Pediatrico Giovanni XXIII
Verified postcode
Bari, Italy· Recruiting
Pediatric Ophthalmology - Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Milan
Verified postcode
Milan, Italy· Recruiting
Azienda Ospedale Università Padova
Verified postcode
Padua, Italy· Not yet recruiting
Children's Memorial Health Institute, Department of Ophthalmology
Verified postcode
Warsaw, Poland· Recruiting
Hospital Universitario Parc Taulí
Verified postcode
Barcelona, Spain· Recruiting
Hospital Puerta del Mar (INIBICA)
Verified postcode
Cadiz, Spain· Recruiting
Hospital Universitario La Paz
Verified postcode
Madrid, Spain· Recruiting
Northern Ireland Clinical Research Facility. U Floor. Belfast City Hospital
Verified postcode
Belfast, United Kingdom· Recruiting
School of Optometry, Aston University
Verified postcode
Birmingham, United Kingdom· Recruiting
R&D, Moorfields Eye Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is myopia?

Myopia is the medical term for short-sightedness, meaning you can see close-up objects clearly but distant objects appear blurry.

What are atropine eye drops?

Atropine eye drops are medicines that have shown promise in slowing down the progression of short-sightedness in children.

What does 'placebo' mean in a study?

A placebo is a 'dummy' treatment, like eye drops with no medicine in them. It's used to compare against the real medicine to see if the medicine truly works.

How long will the study last for my child?

If your child participates, they will be in the study for two years, including daily eye drops and regular hospital visits.

Why is it important to slow down short-sightedness?

Slowing down short-sightedness can help prevent it from becoming very severe, which can reduce the risk of certain eye problems later in life.

How to find out more

Irisi Sukaj

isukaj@cvbf.net +355 68 90 37 854 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.