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Can a daily eye drop stop Kids' eyesight from worsening?

NCT ID NCT07028827

Disease control Sponsor: Ocus Innovation Ireland Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tests whether low-dose atropine eye drops (0.025% and 0.05%) can slow the progression of myopia (nearsightedness) in children and teens aged 3 to 17. About 234 participants across Europe will use the drops once nightly for 2 years. The goal is to see if these drops can keep eyesight from getting worse, reducing the need for stronger glasses later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atropine eye drops (0.025% and 0.05%)
What this could lead to
If successful, this could provide a safe, effective daily eye drop to slow or stop nearsightedness from getting worse in children and teens.
What could go wrong
This is a phase 3 trial, but results may vary by child. Atropine can cause side effects like light sensitivity or blurry near vision. Long-term benefits beyond 2 years are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 234 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

eye disorder myopia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myopia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    11 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedale Università Padova

    NOT_YET_RECRUITING

    Padua, Italy

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Children's Memorial Health Institute, Department of Ophthalmology

    RECRUITING

    Warsaw, Poland

  • Hospital Puerta del Mar (INIBICA)

    RECRUITING

    Cadiz, 11009, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Parc Taulí

    RECRUITING

    Barcelona, 08208, Spain

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

    RECRUITING

    Belfast, BT9 7AB, United Kingdom

  • Ophthalmology - AOU Consorziale Policlinico - Ospedale Pediatrico Giovanni XXIII

    RECRUITING

    Bari, Italy

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

    RECRUITING

    Milan, Italy

  • R&D, Moorfields Eye Hospital

    RECRUITING

    London, United Kingdom

  • School of Optometry, Aston University

    RECRUITING

    Birmingham, United Kingdom

  • University Hospital Centre Mother Teresa (UHCT), Paediatric Department

    RECRUITING

    Tirana, Albania

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