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Study of Atropine Sulfate eye drops (0.

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What is this trial about?

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

This study focuses on treating myopia, also known as nearsightedness, in children. The condition occurs when distant objects appear blurry while close objects remain clear. The research evaluates a new eye drop solution called OT-101 containing atropine sulfate at a concentration of 0.01%.

The purpose of this study is to determine how well these eye drops work in slowing down the progression of myopia in children over a three-year treatment period. The study will compare the effectiveness of OT-101 eye drops against a placebo solution that looks the same but contains no active medication.

During the study, participants will receive either the OT-101 eye drops or placebo drops. The drops will be administered through ophthalmic use (placed directly in the eyes). The treatment will continue for three years, with regular check-ups to monitor changes in vision. The study will measure how the eye drops affect the progression of nearsightedness using specialized eye examinations.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening visit

    Your eye doctor will perform an eye examination using cycloplegic autorefraction (a test that measures your eye's focusing power)

    The doctor will check if your vision meets the required criteria: myopia between -1.00 and -6.00, with astigmatism not exceeding 1.50

    Your vision will be tested using special eye charts (ETDRS or Lea Chart for children who don't know the alphabet)

    If applicable, a pregnancy test will be performed for female participants of childbearing age

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either Atropine Sulfate 0.01% eye drops or placebo eye drops (drops without active medication)

    Neither you nor your doctor will know which type of drops you are receiving

  3. Step 3

    Treatment period

    The treatment will continue for 36 months (3 years)

    You will need to use the assigned eye drops as directed by your doctor

    Regular check-ups will be scheduled to monitor your eye condition

    Your eye measurements will be taken using specialized equipment to track changes in your vision

  4. Step 4

    Final evaluation

    After 36 months, your final eye examination will be performed

    The doctor will measure the change in your eye's focusing power using cycloplegic autorefraction

    The length of your eye will be measured using cycloplegic biometry

    These measurements will help determine if the treatment has helped slow down the progression of myopia (nearsightedness)

Who can join the trial?

13 criteria

  • Parent or legal guardian must provide written informed consent and sign required documentation. Where appropriate, child's agreement to participate should also be obtained
  • Must be able to attend all study visits and understand native language. Parent/legal guardian must accompany the participant
  • Age must be between 3-15 years at the first visit
  • Must have specific vision conditions:
    • Myopia (nearsightedness) between -1.00 and -6.00 diopters
    • Astigmatism (irregular eye shape affecting vision) no more than 1.50 diopters
    • Difference in vision between eyes (anisometropia) must not exceed 1.0 diopters
    • Must have minimum vision requirements based on age:
      • Age 3: vision of 20/50 or better
      • Age 4: vision of 20/40 or better
      • Age 5 and older: vision of 20/30 or better
      • Female participants who can bear children must:
        • Have a negative pregnancy test at screening
        • Not be breastfeeding
        • Use acceptable birth control throughout the study
        • Must be willing to avoid prohibited medications during the study period

Who cannot join the trial?

14 criteria

  • Age below 6 years or above 12 years at the time of enrollment
  • History of eye diseases other than myopia (such as glaucoma, cataracts, or retinal disorders)
  • Previous eye surgery or laser treatment
  • Current use of contact lenses or other vision correction treatments
  • Allergies to eye medications or eye drops
  • Active eye infections or inflammation
  • Participation in other clinical trials within the past 30 days
  • Medical conditions that could affect vision or study participation
  • Unable to follow study instructions or attend regular follow-up visits
  • Known sensitivity to any components of the study medication
  • History of poor compliance with medical treatments
  • Systemic diseases (diseases affecting the whole body) that could impact eye health
  • Inability of parent/guardian to provide informed consent
  • Any condition that, in the investigator's opinion, makes the patient unsuitable for the study
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Investigated drugs

  • OT-101 (Atropine)

    is an eye drop solution used to slow down the progression of nearsightedness (myopia) in children. It works by affecting the way the eye grows and develops during childhood. The medication is applied directly to the eyes and helps prevent the eye from becoming more nearsighted over time. This treatment is being studied as a way to help children maintain better vision as they grow older.

  • Placebo

    is an inactive substance that looks identical to the real medication but contains no active ingredients. It is used as a comparison to determine if the actual medication is effective.

What is already known about the treatment

OT-101 (Atropine Sulfate 0.01%) – A prescription eye drop solution used in the treatment and management of myopia (nearsightedness) progression in children. This medication works by binding to muscarinic receptors in the eye, which influences eye growth and development, helping to slow down the progression of myopia. It belongs to the anticholinergic class of medications and is administered as a topical ophthalmic solution that is applied directly to the eyes. Currently undergoing Phase III clinical trials, this low-concentration formulation represents a promising therapeutic approach for controlling myopia progression in pediatric patients, with research suggesting better tolerability compared to higher concentrations of atropine.

Investigated diseases

Myopia - A vision condition in which close objects are seen clearly, but objects farther away appear blurred. This 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. Myopia typically develops during childhood and adolescence, and may continue to progress until early adulthood. The condition can range from mild to severe, affecting daily activities like reading signs or driving. In children, myopia often worsens as they grow and their eyes continue to develop.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-516315-24-00Protocol codeOT-101-001Estimated enrolment678 patientsSponsorOcumension (Hong Kong) Ltd.

sourced from the EU Clinical Trials Register and site verification

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