A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants with Open-Angle Glaucoma or Ocular Hypertension
This research is looking into a new form of eye drops called Bimatoprost SR. It's for people who have open-angle glaucoma or high pressure inside their eyes (ocular hypertension). The main goal is to see how long the Bimatoprost SR eye drops remain effective in lowering eye pressure, which is important for managing these conditions and protecting your vision. Researchers will also check for any side effects, changes in vision, and examine various parts of the eye. This type of study, called a Phase 3b study, helps confirm the benefits of treatments and how best to use them in real-world situations, building on earlier research.
At a glance
What is this study about?
This study is designed to help us understand more about a new treatment for common eye conditions, specifically open-angle glaucoma and ocular hypertension. These conditions can lead to increased pressure inside the eye, which, if not controlled, can damage the optic nerve and affect your vision over time.
The treatment being studied is called Bimatoprost SR. You might be familiar with Bimatoprost eye drops already. The 'SR' stands for 'sustained release', meaning it's designed to release the medicine slowly over a longer period. The main thing this study wants to find out is how long one application of Bimatoprost SR keeps working to lower eye pressure. This is important for doctors to know how often it needs to be given to effectively manage your condition.
Researchers will also be carefully monitoring other aspects of your eye health. They'll check for any side effects, changes in your vision, including how well you can see and your peripheral (side) vision. They will also look closely at different parts of your eye, like the whites of your eyes, the front of your eye, and the back of your eye where your optic nerve is, to make sure everything is healthy and to understand the full effect of the treatment. This detailed approach helps ensure new treatments are safe and effective.
Key takeaways
- This study is for adults with open-angle glaucoma or high eye pressure.
- It aims to find out how long a new eye drop, Bimatoprost SR, works to lower eye pressure.
- Researchers will closely monitor your eye health and vision during the study.
- Participation involves regular clinic visits for checks and assessments.
- You can stop participating at any time without affecting your medical care.
Who may be eligible?
To be considered for this study, you would need to be an adult, 18 years old or older. There is no upper age limit, meaning people of all adult ages can take part.
Both men and women are welcome to participate in this research. The study needs a wide range of people to understand how the treatment works for everyone.
However, the study is specifically for people who have been diagnosed with either open-angle glaucoma or ocular hypertension. This means if you have other eye conditions or if your eye pressure is normal, this particular study might not be 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?
- Do you have a diagnosis of ocular hypertension (high eye pressure)?
- Are you able to attend regular clinic visits for eye checks?
What does participation involve?
If you decide to take part, you would receive the Bimatoprost SR treatment. During the study, you'd have regular visits to the clinic. At these visits, doctors and nurses would perform various checks to see how the treatment is working and monitor your eye health. These checks might include measuring your eye pressure, assessing your vision (like reading an eye chart and checking your side vision), and looking closely at your eyes with special equipment. They would also ask you about any side effects you might be experiencing. The exact number of visits and the full duration of your participation would be explained to you by the study team.
Potential risks and benefits
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Common questions
What is open-angle glaucoma?
It's a common eye condition where the pressure inside your eye slowly builds up, which can damage the nerve to your brain and affect your vision.
What is ocular hypertension?
This means you have higher than normal pressure inside your eye, but you don't yet have glaucoma. It can increase your risk of developing glaucoma.
What does 'SR' mean in Bimatoprost SR?
SR stands for 'sustained release,' meaning the medicine is designed to work for a longer period after just one dose.
Will I get 'placebo' in this study?
This study is focused on Bimatoprost SR and how long it works. The information suggests participants will receive Bimatoprost SR, but you should always confirm the exact treatment plan with the study team.
How long will the study last for me?
The researchers are looking at the 'duration of effect,' meaning how long the treatment works. The study team will tell you the exact time commitment for your participation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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