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Comparison of Atropine 0.

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on myopia, also known as nearsightedness, a vision condition where distant objects appear blurry while close objects remain clear. The study examines two different concentrations of atropine eye drops (0.5% and 0.05%) to prevent the worsening of myopia in children. Atropine is a medication that has been used in eye care and is being studied for its ability to slow down the progression of nearsightedness.

The study aims to determine which concentration of the eye drops works better in European children who have progressive myopia. Children in the study will receive either the stronger (0.5%) or weaker (0.05%) version of the eye drops. The treatment will continue for several years to understand how well each concentration works in preventing the condition from getting worse.

During the study, doctors will monitor changes in children's vision and eye health. They will also look at how safe the different concentrations are, how well children follow the treatment plan, and what happens after the treatment ends. The eye drops will be given daily, and regular check-ups will help track the children's eye health throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eye doctor will conduct a detailed examination to confirm myopia (nearsightedness) between -1.00 and -6.00 diopters in both eyes

    The doctor will check your eye pressure to ensure it is below 21 mm Hg

    Your medical history will be reviewed to confirm myopia started after age 4

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either atropine 0.05% or atropine 0.5% eye drops

    Neither you nor your doctor will know which concentration you are receiving

  3. Step 3

    Treatment period

    You will need to apply the eye drops to both eyes daily

    The treatment will continue for an extended period to monitor the progression of your myopia

    Regular check-ups will measure changes in your eye length and vision prescription

    Your eye doctor will monitor any side effects and how well you follow the treatment plan

  4. Step 4

    Post-treatment monitoring

    After the treatment period ends, your eyes will be monitored to check for any changes in myopia progression

    The doctor will evaluate how your eyes respond after stopping the eye drops

  5. Step 5

    Study completion

    The study will conclude by January 31, 2031

    Final measurements of your eye length and vision prescription will be taken

    Your participation will help determine which concentration of atropine is more effective for treating childhood myopia

Who can join the trial?

6 criteria

  • Child must be between 6 and 11 years old and have nearsightedness (myopia) in both eyes
  • The child's nearsightedness must have started when they were 4 years or older
  • There must be evidence that the child's nearsightedness has been getting worse over time
  • The child's vision prescription (measured during an eye exam when the pupils are dilated) must be between -1.00 and -6.00 diopters in each eye
  • The pressure inside each eye (intraocular pressure) must be less than 21 millimeters of mercury
  • Both boys and girls can participate in the study

Who cannot join the trial?

10 criteria

  • Children who do not have progressive myopia (nearsightedness where distant objects appear blurry)
  • Children outside the age group of 6-11 years old (indicated by age range category code 2)
  • Children with known allergies to atropine or similar eye medications
  • Children who are currently using other eye medications that could interfere with the study treatment
  • Children with other significant eye conditions besides myopia
  • Children who have participated in another clinical trial within the past 30 days
  • Children who cannot follow the study protocol or attend regular follow-up visits
  • Children with a history of serious eye injuries or surgeries
  • Children who have medical conditions that could affect vision development
  • Children who cannot properly use eye drops or follow treatment instructions
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Investigated drugs

Atropine eye drops are used to slow down the progression of myopia (nearsightedness) in children. This medication works by relaxing the muscles in the eye that control focusing. The eye drops are applied directly to the eyes and help prevent the eye from lengthening, which is what causes increasing myopia. Atropine has been used in eye care for many years and is considered a standard treatment for preventing worsening of nearsightedness in children.

What is already known about the treatment

  • Atropine 0.5% eye drops

    This medication is administered as eye drops directly into the eye, belonging to the anticholinergic class of drugs. It is currently used in ophthalmology for the treatment and prevention of myopia (nearsightedness) progression, particularly in children. The medication works by blocking acetylcholine receptors in the eye, which affects the eye's focusing system and may help slow down the elongation of the eyeball that causes progressive myopia. This formulation represents a higher concentration option in myopia management, being studied in clinical trials to determine its comparative efficacy against lower concentrations.

  • Atropine 0.05% eye drops

    This is a lower concentration formulation of atropine administered as eye drops, belonging to the same anticholinergic class as its stronger counterpart. It is being investigated as a potentially more tolerable option for myopia progression control in children, working through the same mechanism of blocking acetylcholine receptors in the eye. This lower concentration aims to provide effective myopia control while potentially reducing side effects commonly associated with higher concentrations of atropine, making it an important subject of clinical research in pediatric ophthalmology.

Investigated diseases

Myopia - A vision condition where close objects appear clear, but objects farther away look blurry or out of focus. It occurs when the eye grows too long from front to back, or the cornea has too much curvature, causing light rays to focus in front of the retina instead of directly on it. The condition typically develops during childhood and can progress until early adulthood. Myopia can range from mild to severe, affecting a person's ability to see distant objects clearly. The condition often runs in families and can be influenced by both genetic and environmental factors, such as prolonged close-up work or limited outdoor activities.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-516379-34-00Protocol code7098Estimated enrolment550 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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