Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized, double-blind, placebo-controlled dose-finding study of 0.05%, 0.025%, 0.01% and 0.005% atropine eye drops to inhibit myopia progression in children in a European population

This research study is investigating new eye drops to help slow down how quickly short-sightedness (myopia) gets worse in children. Doctors are testing four different strengths of atropine eye drops (0.05%, 0.025%, 0.01%, and 0.005%) against a 'dummy' drop (placebo) that contains no active medicine. The main goal is to find out which strength is most effective at stopping short-sightedness from increasing over a 12-month period. They will also be checking for any side effects and how the drops affect other parts of the eye. This is an important step to find better ways to manage short-sightedness in young people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pharma Stulln GmbH

Enrolment target

135

Start

02 Sep 2024

Myopia progression in children

What is this study about?

This research study is looking for better ways to manage short-sightedness, also known as myopia, in children. Myopia means that faraway objects look blurry, and it often gets worse as children grow. It's important to try and slow down how much short-sightedness increases, as very high levels can sometimes lead to eye problems later in life.

In this study, researchers are testing special eye drops called atropine. Atropine has been used in eye care for a long time, and lower strengths are being explored as a possible way to help slow down the progression of short-sightedness. The study will test four different strengths of atropine drops and compare them to drops that look exactly the same but contain no active medicine – these are called placebo drops. This comparison helps doctors understand if the atropine drops are truly working and which strength is the most effective.

The main aim over the 12 months of the study is to see if these eye drops can prevent short-sightedness from getting worse. They will measure changes in the child's short-sightedness and also look at how the eye grows, as this growth is linked to an increase in short-sightedness. Safety is also a top priority, so the researchers will be carefully checking for any side effects or changes in the eyes while using the drops.

Key takeaways

This study looks at different strengths of atropine eye drops to slow down short-sightedness in children.
Children will use one of four strengths of drops or a dummy (placebo) drop for 12 months.
Regular eye checks will assess vision changes and eye health.
The main aim is to find effective and safe ways to manage increasing short-sightedness.
Participation involves daily drops and regular clinic visits over about a year.

Who may be eligible?

This study is open to children of any age. Both boys and girls can take part.

To join, a child would need to have specific levels of short-sightedness that are getting worse. Doctors and study staff will carefully check eye measurements during the initial health checks to see if your child meets these detailed criteria.

There might be other health conditions or medicines that would prevent a child from being able to join, to ensure their safety and the accuracy of the study results. The study team will discuss all these points with you and your child during the screening process.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child currently experiencing short-sightedness?
Has your child's short-sightedness been getting worse recently?
Is your child able to attend regular eye clinic appointments?
Are you comfortable with your child using eye drops daily for 12 months?
Does your child have any other serious eye conditions?

Answer every question to see your result.

What does participation involve?

If you and your child decide to take part in this study, your child will be randomly assigned to one of five groups: four groups will receive different strengths of atropine eye drops, and one group will receive a placebo (dummy) drop. Neither you, your child, nor the study doctors will know which drops your child is receiving – this helps ensure the study results are unbiased.

Your child will use the assigned eye drops once a day for 12 months. Throughout this year, your child will attend regular visits at the study clinic. These visits will involve various eye tests, including measuring their vision, checking the size and shape of their eye, and looking at the structures inside their eye. Some of these tests might involve using special dilating eye drops temporarily to get clear measurements. The doctors will also ask about any side effects your child might be experiencing.

After the 12 months of using the eye drops, there will be follow-up visits to see how your child's eyes are doing. The total time attending the study will therefore be just over a year, including all follow-up appointments.

Potential risks and benefits

Taking part in a study like this might offer your child the potential benefit of slowing down their short-sightedness, although there's no guarantee the drops will work for every child, especially if they are in the placebo group. It also means your child will receive regular, thorough eye check-ups. Potential risks include side effects from the atropine eye drops, such as temporary blurry vision, increased sensitivity to light (which can be managed with sunglasses), or rarely, other eye irritations or changes. There's always a chance of unknown side effects with any new treatment. You have the right to withdraw your child from the study at any time, for any reason, without affecting their future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is 'myopia progression'?

It means how quickly a child's short-sightedness (blurry vision for distant objects) gets worse over time.

What are atropine eye drops?

Atropine is a medicine that has been used in eye care for a long time. In this study, very low strengths are being tested to see if they can slow down how fast short-sightedness increases.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active ingredients. It helps researchers compare the real medicine's effects.

Will my child know if they are getting the real drops or the placebo?

No, not knowing is called 'double-blind'. Neither your child, you, nor the study doctors will know which drops your child is getting until the study ends. This keeps the results fair and unbiased.

How long will the study last for my child?

Your child will use the eye drops for 12 months and then have follow-up visits, so the total time will be just over a year.