AuthorisedTherapeutic exploratory (Phase II)Interventional

Safety and efficacy of T10430 eye drops in controlling paediatric myopia progression

This study is looking at a new type of eye drop, called T10430, for children and teenagers who are short-sighted. Short-sightedness, or myopia, can get worse over time, so doctors are keen to find ways to slow this down. The main goal of this research is to check how safe these new eye drops are. This means carefully watching for any side effects in the eyes. They will also be looking to see if the drops help to control how much the short-sightedness progresses by measuring changes in eye length and vision over time. This is a Phase II study, which means it’s an early stage of testing new medications.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Laboratoires Thea

Enrolment target

Start

22 May 2026

Paediatric myopia

What is this study about?

This study is testing new eye drops called T10430. They are designed for children and teenagers who are short-sighted, a condition also known as myopia. Myopia means distant objects look blurry, and it can sometimes get progressively worse, especially during childhood and teenage years. Doctors are researching new treatments to help slow down this progression and protect children's eyesight in the long term.

The main purpose of this study is to find out if these new T10430 eye drops are safe for children to use. The researchers will be closely watching for any unwanted effects or reactions in the eyes. This is the most important part of the study at this stage. They are also looking to see if the drops are effective in controlling how quickly short-sightedness gets worse. This involves measuring various aspects of the eye, like how long the eyeball is and how clear vision is, over a period of time.

By taking part in this study, children and their families would be helping doctors understand if this new treatment could be a safe and helpful option for managing short-sightedness in the future. The information gathered will be vital for developing better treatments for children with myopia.

Key takeaways

This study is for children with short-sightedness (myopia).
It's testing new eye drops (T10430) to see if they are safe and can slow down worsening vision.
The most important goal is to check for any side effects in the eyes.
Participation involves using eye drops and having regular eye check-ups for about a year.
It's a step towards finding better treatments for short-sightedness in children.

Who may be eligible?

This study is open to both boys and girls of all ages who have short-sightedness (myopia).

The study team will check your child's medical history and current eye health to make sure they can safely take part. They will also need to confirm that your child's short-sightedness fits the specific criteria for the study.

It's important to understand that even if your child has short-sightedness, there might be other reasons why they can't join the study, such as other health conditions or medications they are currently taking. The study team will discuss all of this with you.

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.

Does my child have short-sightedness (myopia)?
Is my child currently healthy apart from their myopia?
Is my child able to attend regular clinic appointments for about a year?
Am I, as a parent or guardian, comfortable with my child using new eye drops under supervision?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive the T10430 eye drops, which are preservative-free. They will need to use these drops regularly as instructed by the study team. Over a period of several months, your child will have regular check-ups at the clinic. These visits will involve various eye tests to see how their vision is changing and to check for any side effects from the drops. The tests might include measuring the length of their eyeball, checking their vision at different distances, and examining the surface of their eye. The total duration of participation in the study is likely to be around 12 months, with appointments scheduled at specific times (like 1 month, 6 months, and 12 months) as well as initial screening visits.

Potential risks and benefits

Taking part in this study could offer several potential benefits. Your child might receive a new treatment that could help slow down the progression of their short-sightedness, and they will receive close medical attention and monitoring of their eye health. However, as with any new medication, there are potential risks. The eye drops might cause temporary discomfort, redness, or other side effects in the eyes. All known potential risks will be thoroughly explained to you by the study team. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their usual 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
Ireland

Common questions

What is myopia?

Myopia is the medical term for short-sightedness, where distant objects appear blurry.

What are the T10430 eye drops for?

These eye drops are being tested to see if they can safely slow down how much short-sightedness gets worse in children.

What does 'Phase II' mean for this study?

Phase II means this is an early stage study, focusing on how safe the treatment is and if it shows signs of being effective.

Will my child have to visit the clinic often?

Yes, there will be several visits over about a year for eye checks and to monitor their progress and safety.

Can my child stop taking part if we change our mind?

Yes, you can withdraw your child from the study at any time, for any reason, and it won't affect their regular medical care.