Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients with Open Angle Glaucoma or Ocular Hypertension

This research is an extension study for people with open-angle glaucoma or ocular hypertension (high pressure inside the eye). It's designed to check the long-term safety and effectiveness of a treatment called Bimatoprost SR. This treatment is a special, long-lasting formulation. The main goal is to see how long people can go without needing extra treatment or another dose of Bimatoprost SR after their initial treatment. Researchers will also be looking at how long people who previously had a laser treatment (SLT) can go without needing more help. By understanding these things, doctors hope to find better ways to manage these eye conditions, protect eyesight, and improve quality of life for patients. The study involves regular eye checks and assessments.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

AbbVie Deutschland GmbH & Co. KG

Enrolment target

Start

24 Nov 2023

Open-angle Glaucoma Ocular Hypertension

What is this study about?

This study is an important next step in looking at a treatment for two common eye conditions: open-angle glaucoma and ocular hypertension. Open-angle glaucoma is a leading cause of blindness, where pressure inside the eye gradually damages the optic nerve, which sends images to the brain. Ocular hypertension means you have high pressure in your eye, making you more likely to develop glaucoma.

The treatment being studied is called Bimatoprost SR. It's designed to be a slow-release version of a medicine already used to lower eye pressure. This means it might be given less often, which could make managing these conditions easier for patients. This study is an 'extension trial', meaning it follows on from earlier research to check how safely and effectively the treatment works over a longer period. This long-term information is really important for doctors to understand if the treatment provides lasting benefits and helps protect your vision over many years.

Researchers will be looking at several things, like whether patients need other treatments, how their vision is, and general eye health. They want to see how long the Bimatoprost SR treatment keeps eye pressure under control before another treatment is needed. This helps doctors work out the best treatment plans to slow down or prevent further eye damage. Finding a long-lasting and effective treatment can make a big difference in people's lives, helping them maintain their eyesight and independence.

Key takeaways

The study assesses a long-lasting eye treatment (Bimatoprost SR) for glaucoma or high eye pressure.
It aims to understand how safe and effective the treatment is over an extended period.
The main goal is to see how long the treatment keeps eye pressure down before more help is needed.
Participants will have regular eye checks, including vision and eye pressure assessments.
This research could lead to improved, more convenient treatments for eye conditions.
You have the right to leave the study at any time if you choose to.

Who may be eligible?

To take part in this study, you generally need to be an adult, aged 18 or older. Both men and women are welcome to participate.

Crucially, you must have a diagnosis of either open-angle glaucoma or ocular hypertension. These are conditions where the pressure inside your eye is too high, which can damage the nerve that connects your eye to your brain.

This is an 'extension' study, which means it likely follows on from previous research. Patients in this study would probably have already taken part in an earlier study involving Bimatoprost SR or a similar laser treatment (SLT). The research team will check if you meet all the specific criteria from those previous studies to ensure this next phase is suitable for 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.

Are you 18 years old or older?
Do you have a diagnosis of open-angle glaucoma?
Or do you have a diagnosis of ocular hypertension (high eye pressure)?
Did you take part in an earlier study involving Bimatoprost SR or a specific laser treatment (SLT)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it's an extension of a previous one, meaning you've likely already experienced some of the procedures. You'll continue to receive the Bimatoprost SR treatment. Over the course of the study, you'll have regular hospital or clinic visits. During these visits, doctors and nurses will perform various checks on your eyes. These will include looking at your vision, checking your eye pressure, examining your optic nerve (which is vital for sight), and taking detailed pictures of your eye structures.

They will also monitor for any side effects and assess how well the treatment is working to keep your eye pressure stable. The main goal is to see how long you can go without needing additional treatment for your eye condition. The total duration of your participation will depend on how your eye health progresses and how long the researchers need to collect data, but it's set up to assess long-term effects.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving close medical monitoring and access to a long-acting treatment for your eye condition. This might help manage your glaucoma or high eye pressure more effectively and potentially reduce the frequency of other treatments. However, there are also potential risks; treatments can have side effects, and some people might not respond to the medication as expected. You might experience common side effects associated with eye drops, or the treatment might not be effective for you. It's crucial to remember that participation is completely voluntary, and you have the right 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
Poland
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Unverified
Germany
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Unverified
France
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Unverified
Spain

Common questions

What is open-angle glaucoma?

It's an eye condition where the pressure inside your eye gradually goes up, slowly damaging the nerve that sends signals from your eye to your brain. This can lead to vision loss if not treated.

What is ocular hypertension?

This simply means you have higher than normal pressure inside your eye, but without any damage to your optic nerve yet. It can increase your risk of developing glaucoma.

What is Bimatoprost SR?

It's a special, long-lasting version of a medicine (Bimatoprost) that's used to help lower pressure inside the eye. SR stands for 'slow release', meaning it works over a longer period.

Why is this study important for me?

If you have glaucoma or ocular hypertension, this study could help doctors find better, longer-lasting treatments. It aims to see if Bimatoprost SR can help protect your vision over many years.

Will I have to pay to take part?

No, you should not have to pay to take part in a clinical trial. All study-related treatments and tests are usually provided free of charge.