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Eye drops face off to halt Kids' worsening nearsightedness

NCT ID NCT05667454

Disease control Sponsor: Erasmus Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers compare two strengths of atropine eye drops, 0.05% and 0.5%, in Dutch children aged 6 to 11 with progressive nearsightedness. About 550 children use the drops for three years, then researchers follow them for two more years. The goal is to see which strength better slows the eye's growth, measured by axial length and glasses prescription, and to track side effects and adherence.

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
What this could lead to
If one strength works better, doctors could have a clearer choice for slowing myopia in children and reducing the risk of severe nearsightedness later in life.
What could go wrong
Atropine eye drops can cause light sensitivity and blurry near vision, and children may still need glasses. Slowing eye growth in childhood does not guarantee a lifetime without vision problems.

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 550 people

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

Started

Dec 2022

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

6 to 11 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: * Children aged 6 to ≤ 11 years with bilateral myopia * Onset of myopia ≥ 4 years of age * History of progression * SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction * Intraocular pressure \< 21 mm Hg in each eye * Distance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angle of resolution) in each eye Exclusion Criteria: * Allergy to atropine or other excipients of the eye drops * History of amblyopia or strabismus * History of retinal dystrophy or systemic disorder * Abnormal ocular biometry aside from axial length * History of glaucoma * Chronic use of topical or systemic antimuscarinic/anticholinergic medications in the 21 days prior to screening, and/or anticipated need for chronic use over the duration of the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30 days in 1 year). * Chronic use (more than 3 days a week) of topical ophthalmological medication (prescribed or over the counter) other than the assigned study medication. The use of artificial tears is allowed but not in the 1 hour before or after the administration of the study medication. * The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. (i.e., \< 2 weeks) * Prior myopia treatments. * Employees of the study center and their family members.

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Conditions

The condition(s) this trial relates to.

degenerative myopia myopia

As listed by the trial registrant

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

Progressive myopia

Contacts and locations

Locations

  • Admiraal de Ruyter Ziekenhuis

    Goes, Netherlands

  • Albert Schweitzer ziekenhuis

    Dordrecht, Netherlands

  • Bergman Clinics - Ede

    Ede, Netherlands

  • Bergman Clinics - Lelystad

    Lelystad, Netherlands

  • Deventer Ziekenhuis

    Deventer, Netherlands

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg, Netherlands

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • Flevoziekenhuis

    Almere Stad, Netherlands

  • Frisius MC

    Heerenveen, Netherlands

  • Haga Ziekenhuis

    The Hague, Netherlands

  • Leiden University Medical Center

    Leiden, Netherlands

  • Maastricht UMC+

    Maastricht, Netherlands

  • OLVG, locatie Oost

    Amsterdam, Netherlands

  • Oogcentrum Noordholland

    Heerhugowaard, Netherlands

  • Oogkliniek Den Haag

    The Hague, Netherlands

  • Ophthalmologistenpraktijk Delfland

    Delft, Netherlands

  • Radboudumc

    Nijmegen, Netherlands

  • Reinier de Graaf Gasthuis

    Delft, Netherlands

  • St. Antonius

    Nieuwegein, Netherlands

  • Ziekenhuis Rivierenland Tiel

    Tiel, Netherlands

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