Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

SEER-3: A Phase 3, Multi-Center, Randomized, Parallel, Double Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy

This research study, called SEER-3, is looking into a new eye drop called RGN-259 (containing timbetasin acetate 0.1%) for people with a rare eye condition called Neurotrophic Keratopathy (NK). NK affects the clear front part of the eye (the cornea) and can lead to slow-healing sores. The main goal is to find out if this new eye drop helps heal these sores completely on the eye's surface over about a month, compared to a placebo (a dummy drop with no active medicine). We will also be carefully checking for any side effects to make sure the treatment is safe. This is a Phase 3 study, meaning it's one of the final steps before a new medicine might be approved for wider use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Regentree LLC

Enrolment target

Start

07 Jun 2023

Neurotrophic Keratopathy

What is this study about?

Neurotrophic Keratopathy (NK) is an uncommon eye condition where the nerves in the clear front part of your eye, called the cornea, don't work as well as they should. These nerves are really important for keeping the eye healthy, protecting it from harm, and telling your brain if something is wrong. When these nerves are damaged, it can make it harder for your eye to heal, leading to sores or wounds on the surface of the eye that don't go away easily. This can cause discomfort, blurry vision, and in severe cases, might even affect your eyesight.

Traditional treatments can sometimes help, but doctors are always looking for better ways to heal these stubborn sores and improve eye comfort. This study is testing a new eye drop that contains a medicine called timbetasin acetate. The researchers hope this medicine might help the eye heal itself more effectively. They want to see if it can completely heal the sores on the eye's surface, which is a major problem for people with NK, and do so more quickly than existing options.

To do this, some participants will receive the new eye drop, while others will be given a 'dummy' eye drop (a placebo) that looks and feels the same but contains no active medicine. This helps the researchers accurately compare the effects of the new medicine. Everything will be carefully monitored, including how well the sores heal, any changes in your vision or eye comfort, and any unexpected effects. The information gathered will help determine if this new eye drop could be a valuable treatment option for people living with NK.

Key takeaways

This study tests a new eye drop (RGN-259) for Neurotrophic Keratopathy.
The main goal is to see if it helps heal eye surface sores better than a dummy drop.
It's a 'double masked' study, meaning neither you nor your doctor will know which treatment you're getting.
Participants will have multiple clinic visits over about a month for eye exams and monitoring.
The study helps determine if RGN-259 could become a new treatment option for NK.

Who may be eligible?

To join this study, you would generally need to be an adult, aged 18 years or older.

The study is open to both men and women.

Because this study focuses on a specific eye condition called Neurotrophic Keratopathy, you would need to have this diagnosis to be considered. There will be other specific medical checks to make sure the study treatment is suitable and safe for you, as well as to ensure the study results are clear and reliable. These checks will usually involve reviewing your medical history and having some eye examinations.

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?
Do you have a diagnosis of Neurotrophic Keratopathy?
Are you able to attend several clinic appointments over about a month?
Are you generally in good health other than your eye condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening visit to see if you meet all the requirements. If you do, you'll be randomly assigned to either receive the new eye drop or a dummy eye drop, like tossing a coin. Neither you nor your study doctor will know which one you are receiving – this is called 'double masked'.

You would need to use your assigned eye drops regularly as instructed. Over about 29 days, you will have several visits to the study clinic (around 5-7 visits in total). During these visits, the study team will perform various checks and assessments. This will include careful eye examinations, like looking at the front of your eye with a special light (slit-lamp exam) and using a special dye to see if any sores are healing. They will also check your eyesight, measure your eye pressure, and ask about your symptoms and how your eyes feel. Your general health, including vital signs like your heart rate, will also be monitored. The total duration of active treatment and follow-up for the main part of the study is about a month.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and closely monitored medical care. It also means contributing to medical knowledge that could help others with Neurotrophic Keratopathy in the future. However, there are potential risks, including side effects from the eye drops, which could range from mild irritation to more serious reactions, just like any medication. You will also need to attend multiple appointments. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Italy
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Unverified
Spain
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Unverified
Germany
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Unverified
Poland

Common questions

What is Neurotrophic Keratopathy (NK)?

NK is an eye condition where the nerves on the surface of your eye (cornea) are damaged, making it harder for your eye to heal from injuries or sores.

What is a 'placebo' in this study?

A placebo is a 'dummy' eye drop that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects.

Will I know if I'm getting the new eye drop or the dummy one?

No, neither you nor your doctor will know, as this is a 'double masked' study. This ensures the results are as fair and accurate as possible.

How long will I be in the study?

The main part of the study, including treatment and follow-up, will involve visits over about 29 days (roughly one month).

What does a 'Phase 3' study mean?

Phase 3 means this is one of the final stages of testing a new treatment. It's designed to confirm the treatment's safety and effectiveness in a larger group of people before it can potentially be approved for use.