Study on Atropine Sulfate Eye Drops to Slow Down Myopia in European Children

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What is this study about?

This clinical trial is focused on studying the progression of myopia, commonly known as nearsightedness, in children. The study aims to find the best dose of atropine sulfate eye drops to slow down the worsening of myopia. Atropine sulfate is a medication used in eye drops to help relax the eye muscles and is being tested in different low doses: 0.05%, 0.025%, 0.01%, and 0.005%. A placebo eye drop, which does not contain the active medication, is also used for comparison.

The purpose of the study is to determine the most effective dose of atropine sulfate eye drops for reducing the progression of myopia in children. Participants in the study will receive one of the different doses of atropine sulfate eye drops or a placebo. The study will last for about a year, during which the children will have regular check-ups to monitor changes in their vision and eye health. These check-ups will include measuring the growth of the eye, the depth of the front part of the eye, and other aspects of eye function.

Throughout the study, the safety of the atropine sulfate eye drops will be closely monitored. This includes checking for any side effects that might occur in the eyes or elsewhere in the body. The study will also look at how the eye drops affect different eye colors, as well as any changes in vision clarity and eye pressure. The goal is to ensure that the treatment is both effective and safe for children with myopia.

1 joining the study

The study involves children aged 6 to 12 years with myopia, a condition where distant objects appear blurry.

Participants must have shown myopia progression in the past year and meet specific vision criteria.

Parents or guardians must provide consent for participation.

2 randomization and treatment assignment

Participants are randomly assigned to receive one of the following treatments: atropine sulfate eye drops at concentrations of 0.005%, 0.01%, 0.025%, 0.05%, or a placebo.

The study is double-blind, meaning neither the participants nor the researchers know which treatment is being administered.

3 administration of eye drops

Eye drops are administered topically, meaning they are applied directly to the eyes.

The frequency and duration of administration are determined by the study protocol and are consistent for all participants.

4 monitoring and assessments

Participants undergo regular assessments to monitor changes in myopia over a 12-month period.

Primary assessments include measuring changes in vision using an autorefractor, a device that measures how light is changed as it enters the eye.

5 secondary assessments

Additional assessments include measuring eye growth, lens thickness, pupil size, and visual acuity.

The effects of atropine on different eye characteristics, such as iris pigmentation, are also evaluated.

6 safety monitoring

Safety is monitored by checking for any adverse reactions to the eye drops, both locally in the eye and systemically throughout the body.

Participants and caregivers report any side effects, and investigators assess these reports.

7 completion of the study

The study is expected to conclude in June 2025, after which the data will be analyzed to determine the optimal dose of atropine for inhibiting myopia progression.

Who Can Join the Study?

Children who are boys or girls, aged between 6 and 12 years old.
Girls who have started their menstrual cycle must use a very effective method to prevent pregnancy, with a failure rate of less than 1% per year.
Children must have myopia (nearsightedness) with a measurement between -1.0 and -4.0 diopters (a unit to measure the strength of glasses or contact lenses) in at least one eye.
There must be a noticeable worsening of myopia in the past year in at least one eye.
Parents or legal guardians must be informed about the study and must sign a form agreeing to let their child participate.

Who Cannot Join the Study?

Children who have any eye diseases other than myopia (nearsightedness) cannot participate.
Children who have had eye surgery in the past cannot participate.
Children who are currently using other eye medications cannot participate.
Children with allergies to atropine or any of its ingredients cannot participate. Atropine is a medication used in eye drops.
Children with any serious health conditions that might affect the study cannot participate.
Children who are not able to follow the study instructions cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Internationale Innovative Ophthalmochirurgie GbR (I.I.O.)	Duesseldorf	Germany
Saarland University Hospital	Homburg	Germany
Mfw Aumjmh uhf Lyrwuummoibm Mnqmaithhkxrmitml Gdax	Leipzig	Germany
Kvktdwsynmv if Swkbbjwkvs	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.08.2022

Trial locations

Investigated drugs:

Atropine Eye Drops are being studied to find the best dose to slow down the progression of myopia, which is also known as nearsightedness, in children. These eye drops are used in low doses to help prevent the eyes from getting worse over time. The study is testing different strengths of atropine to see which one works best for children in a European population.

Investigated diseases:

Myopia

Myopia – Myopia, also known as nearsightedness, is a common vision condition where distant objects appear blurry while close objects can be seen clearly. It occurs when the eye grows too long from front to back, causing light rays to focus in front of the retina instead of directly on it. This condition often begins in childhood and can progress as the child grows. The progression of myopia can lead to an increase in the degree of nearsightedness, requiring stronger corrective lenses over time. Factors such as genetics and environmental influences, like prolonged near work or limited outdoor activities, can contribute to its development. Regular eye examinations are important to monitor changes in vision and eye health.

Trial ID:

2024-516758-23-00

Protocol code:

PSt012021

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Atropine Sulfate Eye Drops to Slow Down Myopia in European Children

What is this study about?

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