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Can a simple eye drop slow down worsening nearsightedness in kids?

NCT ID NCT07329777

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether low-dose atropine eye drops (0.025%) can safely slow the progression of myopia (nearsightedness) in children aged 5 to 10. Over two years, 144 children will receive either the active drops or a placebo. The goal is to see if the drops reduce how quickly their eyesight gets worse.

What this could mean

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

Active substance
low-dose atropine sulfate eye drops (0.025%)
What this could lead to
If it works, this could provide a safe, daily eye drop option to slow down worsening nearsightedness in children, reducing the need for stronger glasses later.
What could go wrong
This is a relatively small, early-phase trial (144 children) and the effect may be modest. Atropine can cause light sensitivity or blurry near vision, and long-term safety beyond 2 years is 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 144 people

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

Started

Sep 2025

Expected to finish

Sep 2029

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

5 to 10 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: 1. Male or female children between 5 to 10 years of age. 2. Children with refractive error of spherical equivalent -1.00 D up to -6.00 D in each eye. 3. Children with active myopia progression of at least spherical equivalent -0.50 D within the last 12 months. 4. Children with astigmatism of less than -1.50 D 5. Children having distance vision correctable to logMAR 0.2 or better in both eyes. 6. A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D. 7. Children with normal intraocular pressure of not greater than 21 mmHg in either eye. 8. Children with normal ocular health other than myopia. 9. Children must be in good general health with no history of cardiac or respiratory diseases as per investigator's discretion and does not affect the study treatment or subsequent follow-ups. 10. No asthma-requiring medications in the past one year. 11. No known allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride. 12. Willing and able to comply with scheduled visits and other study procedures. 13. Written Informed Consent from parent and assent from child has been obtained. Exclusion Criteria: 1. History of hypersensitivity or allergy to study drug and/or any of the study medication ingredients. 2. Children with prior and/or concomitant use of other myopia control drugs, contact lens or spectacles (except normal spectacles including tinted/anti-glare glasses) etc. 3. Children with congenital myopia. 4. Children using Ortho K and Myopia Lens. 5. Children with ocular or systemic diseases which may affect vision or refractive error. 6. Children with any ocular condition wherein topical atropine is contraindicated. 7. Children with defective binocular function or stereopsis. 8. Children with amblyopia (lazy eyes) or manifest strabismus including intermittent tropia. 9. Previous or current use of atropine or pirenzepine. 10. Children with any other conditions precluding adherence to the protocol including unwillingness to refrain from the use of other myopia control drug, contact lens or spectacles (except normal) spectacles including tinted/anti-glare glasses) etc. for the duration of the study. 11. Children with any other condition which may put the subject to risk during study or affect study results based on investigator's judgement. 12. Children participated in any clinical study within 30 days prior to randomization.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Hospital Pakar Kanak-Kanak UKM

    RECRUITING

    Kuala Lumpur, Cheras, 56000, Malaysia

  • Universiti Malaya Medical Centre

    RECRUITING

    Kuala Lumpur, Petaling Jaya, 50603, Malaysia

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