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Daily eyedrops may curb worsening nearsightedness in kids

NCT ID NCT03334253

Disease control Sponsor: Jaeb Center for Health Research 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests whether daily low-dose atropine eyedrops (0.01%) can slow the progression of myopia (nearsightedness) in children aged 5 to 12. Participants receive either atropine or placebo drops for two years, followed by six months off treatment to see if any benefit lasts. The goal is to find a safe, easy way to reduce how quickly children's eyesight worsens.

What this could mean

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

Active substance
Atropine (0.01% eyedrops)
What this could lead to
If effective, this could provide a simple, daily eyedrop treatment to slow worsening nearsightedness in children, potentially reducing the need for stronger glasses or future eye problems.
What could go wrong
This is a Phase 3 trial, but results may show only a modest effect or no benefit over placebo. Side effects from atropine, such as light sensitivity or blurry near vision, are possible. The treatment requires daily adherence for years.

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

200 people

The number who actually took part.

Started

Jun 2018

Finished

Sep 2022

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

5 to 12 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: * Age 5 years to \<13 years at time of enrollment. Children within 4 weeks of their 13th birthday are not eligible. * Refractive error meeting the following by cycloplegic autorefraction: * Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes * Astigmatism \<=1.50D in both eyes * Anisometropia \<1.00D SE * Gestational age ≥ 32 weeks. * Birth weight \>1500g. * Parent understands the protocol and is willing to accept randomization to atropine or placebo. * Is willing to participate in a 2 to 4 week run-in phase using daily artificial tear eyedrops. * Able to return in 2 to 4 weeks for possible randomization. * Parent has a phone (or access to phone) and is willing to be contacted by Investigator's site staff. * Relocation outside of the area of an active PEDIG site within next 32 months is not anticipated. Exclusion Criteria: * Current or previous myopia treatment with atropine, pirenzepine or other anti-muscarinic agent. * Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses. * Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression. * Known atropine allergy. * Abnormality of the cornea, lens, central retina, iris or ciliary body. * Current or prior history of manifest strabismus, amblyopia, or nystagmus. * Prior eyelid, strabismus, intraocular, or refractive surgery. * Down syndrome or cerebral palsy. * Females who are pregnant, lactating, or intending to become pregnant within the next 30 months. * A negative urine pregnancy test will be required for all females who have experienced menarche.

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Conditions

The condition(s) this trial relates to.

myopia

As listed by the trial registrant

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

Myopia

Contacts and locations

Locations

  • Boston Children's Hospital Waltham

    Boston, Massachusetts, 02453, United States

  • Casey Eye Institute

    Portland, Oregon, 97239, United States

  • Dean A. McGee Eye Institute, University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

  • Eye Care Associates, Inc.

    Poland, Ohio, 44514, United States

  • Illinois College of Optometry

    Chicago, Illinois, 60616, United States

  • Pediatric Ophthalmology Associates, Inc.

    Columbus, Ohio, 43205, United States

  • Rocky Mountain Eye Care Associates

    Salt Lake City, Utah, 84107, United States

  • St Luke's Hospital

    Boise, Idaho, 83702, United States

  • The Emory Eye Center Dept of Ophthalmology

    Atlanta, Georgia, 30322, United States

  • Ticho Eye Associates

    Chicago Ridge, Illinois, 60415, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Houston College of Optometry

    Houston, Texas, 77204, United States

  • Vanderbilt University Medical Center - Vanderbilt Eye Institute

    Nashville, Tennessee, 37232, United States

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