Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Assess the Safety and Efficacy of SYD-101 Ophthalmic Solution for the Treatment of Myopia in Children

This important study is looking into a new eye drop, SYD-101, designed to help children who are short-sighted, a condition also known as myopia. Myopia means distant objects look blurry, and it can sometimes get worse over time. Researchers want to find out if SYD-101 can effectively slow down this worsening. The study will run for two years and involves comparing the new eye drop to a 'dummy' eye drop that doesn't contain any active medicine, but looks and feels the same. This allows scientists to see the true effect of SYD-101. They'll be carefully checking how much the children's short-sightedness changes and if there are any side effects. The goal is to see if this new treatment could be a safe and effective way to manage myopia in children.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Sydnexis Inc.

Enrolment target

Start

18 Apr 2024

Myopia

What is this study about?

Many children today develop short-sightedness, or myopia, which makes it harder for them to see things far away. For some children, their short-sightedness can get progressively worse. This study is a chance to explore a new treatment, an eye drop called SYD-101, that a company has developed with the hope of slowing down how quickly short-sightedness gets worse in children.

To make sure the results are fair and accurate, this study will compare SYD-101 with a 'dummy' eye drop. This dummy eye drop looks exactly like SYD-101 but doesn't actually contain the active medicine. Neither the child, their parents, nor the doctors will know whether they are receiving the actual medicine or the dummy eye drop – this is to prevent anyone's expectations from influencing the results. The main thing the researchers are looking at is whether SYD-101 can significantly reduce the speed at which a child's short-sightedness progresses over a two-year period.

They will also be carefully monitoring for any unwanted effects and how the children generally tolerate the eye drops. This type of study, called a Phase 3 trial, is a very important step before a new medicine can be considered for wider use. It helps confirm if a treatment is safe and works well enough to help patients. By participating, families can contribute valuable information that could help many other children with myopia in the future.

Key takeaways

This study tests a new eye drop (SYD-101) for short-sightedness (myopia) in children.
It aims to see if SYD-101 can slow down the worsening of myopia over two years.
Participants will receive either the active eye drop or a dummy eye drop, without knowing which.
Regular, detailed eye check-ups will be provided as part of the study.
The total study duration, including follow-up, is three years.
You can withdraw from the study at any time without affecting your child's care.

Who may be eligible?

This study is particularly looking for adults aged 18 years and above to take part. Both men and women are welcome to participate. Currently, the information about the specific age range for children in the trial isn't detailed, but for an adult study, this means individuals from their 18th birthday onwards can be considered.

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.

Are you 18 years old or older?
Are you interested in participating in a study about short-sightedness?
Are you able to attend regular eye appointments for up to three years?
Do you understand that you might receive a dummy eye drop instead of the active medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be helping researchers understand how the eye drops affect children with myopia over a two-year period. You would be given either the active eye drop (SYD-101) or a dummy eye drop, but neither you nor the doctors would know which one you're receiving. This ensures the study results are fair.

Throughout the study, you would attend regular appointments for detailed eye check-ups. These check-ups would involve measuring how much your short-sightedness changes and assessing the overall health of your eyes. Researchers will also be asking about how you feel and if you experience any side effects. For female participants of childbearing potential, pregnancy tests would also be part of the routine check-ups. The total duration of active treatment and close monitoring would be for 24 months (two years), followed by a further 12 months (one year) of observation after you stop using the eye drops, making the total follow-up period three years.

Potential risks and benefits

Participating in this study means you could potentially benefit from a new treatment that might slow down the worsening of short-sightedness, which could be very helpful for your child's long-term eye health. Even if your child receives the dummy drops, the regular, in-depth eye check-ups provided free of charge are a benefit in themselves. However, as with any medication, there's always a chance of side effects from the SYD-101 eye drops, or even from the dummy drops. The study team will be carefully monitoring for any such effects. You are free to withdraw from the study at any time, for any reason, without it affecting your child's usual medical care.

Locations (2)

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

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Unverified
Slovakia
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Unverified
Austria

Common questions

What is myopia?

Myopia is the medical term for short-sightedness, where distant objects appear blurry because light focuses in front of the retina instead of directly on it.

What is a 'dummy' eye drop?

A dummy eye drop, also called a placebo or 'vehicle', looks exactly like the real medicine but doesn't contain any active ingredient. It helps researchers compare the effects of the active medicine fairly.

How long will the study last?

The study will involve active treatment and monitoring for two years (24 months), followed by another year (12 months) of observation after stopping the eye drops, making a total of three years.

Will I know if my child is getting the real medicine?

No, neither you nor your doctor will know whether your child is receiving the active SYD-101 eye drops or the dummy eye drops. This is normal practice in clinical trials to ensure fair and unbiased results.

What if we want to stop participating?

You are completely free to withdraw from the study at any time, for any reason, without needing to explain why, and it will not affect your child's standard medical care.