Bioequivalence study on aqueous humour concentrations of active ingredients after topical application of LEVIOSA® versus F2904. Randomized, parallel-group, blinded-assessor study in patients undergoing cataract surgery – BreAK Free
This research study, called 'BreAK Free,' is looking at two types of eye drops, called LEVIOSA® and F2904. The main goal is to find out if these two eye drops deliver a similar amount of important medicine into the fluid at the front of your eye after you use them. This is important to make sure new medicines work just as well as other ones that are already approved. We are looking for people who are aged 18 or older and are planning to have cataract surgery. You will be randomly assigned to receive one of the eye drops. This study helps doctors understand how well eye treatments get into your eye, which is a key step in developing new and effective medicines.
At a glance
What is this study about?
This study is called 'BreAK Free' and it's looking at how two different eye drops work in people who are having cataract surgery. The drops are called LEVIOSA® and F2904. The main aim is to check if these two eye drops get the same amount of the active medicine into the clear fluid at the front of your eye, which is called aqueous humor. Think of it like comparing two different ways to deliver a parcel – we want to make sure both ways get the same parcel to the right place and at the right concentration.
This type of study is called a 'bioequivalence study.' This means researchers want to see if a new version of a treatment is 'equivalent' or just as effective as an existing one. It's a standard and really important step in developing new medicines. If a new medicine is bioequivalent to an existing one, it means it should work in the same way and have similar effects.
Understanding how much medicine gets into the eye is crucial for treating eye conditions properly. This study helps ensure that eye drops designed to treat conditions like cataracts can deliver the right amount of medicine where it's needed most. This research is a key part of making sure any new eye treatments are safe and effective for people across the UK.
Key takeaways
- Compares two different eye drops: LEVIOSA® and F2904.
- Aims to see if both drops deliver the same amount of medicine into the eye.
- For adults aged 18+ who are having cataract surgery.
- Participation involves using eye drops and a small fluid sample taken during surgery.
- Helps develop new, effective eye treatments.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adults who are at least 18 years old. Both men and women are welcome to take part. The most important requirement is that you must be planning to have surgery for cataracts.
There might be other specific reasons why you can or cannot join, but these are generally related to your overall health and other medications you might be taking. The study team will review all your information carefully to make sure the study is safe for you and that the results will be clear.
If you're interested, the research team will ask you some questions about your health and medical history to confirm if you meet all the requirements. It's important to be open and honest during this process.
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 planning to have cataract surgery?
- Are you able to attend appointments related to the study?
- Are you willing to use eye drops as instructed for a short period?
- Are you comfortable with a small fluid sample being taken during your cataract surgery?
What does participation involve?
If you decide to join this study, you will first have a screening visit to make sure you are suitable. During this visit, you'll get detailed information about the study and have the chance to ask any questions. If you agree to take part, you'll be asked to sign a consent form.
You will be randomly assigned to use either the LEVIOSA® or F2904 eye drops. You won't know which one you are getting, and neither will the doctors doing some of the assessments – this helps make the study results fair and unbiased. You'll use the eye drops as instructed for a short period before your scheduled cataract surgery.
During your cataract surgery, a small sample of the fluid from the front of your eye (aqueous humor) will be collected. This is a very common part of cataract surgery and will be done at the same time as your operation. There won't be any extra procedures just for the study. After surgery, there will typically be a follow-up visit, which might be combined with your usual post-surgery check-up. The overall duration of your involvement in the study will be quite short, mainly focused around your surgery date.
Potential risks and benefits
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Common questions
What is a cataract?
A cataract is when the natural lens inside your eye becomes cloudy, making your vision blurry. Surgery is usually done to remove the cloudy lens and replace it with a clear artificial one.
What does 'randomly assigned' mean?
It means you'll be put into one of the two treatment groups (LEVIOSA® or F2904) by chance, like flipping a coin. Neither you nor the study team gets to choose which one you receive, which helps keep the study fair.
Will I know which eye drops I'm using?
No, you won't know if you're using LEVIOSA® or F2904. This is called 'blinding' and helps ensure that knowing which treatment you're on doesn't influence how you or the study team report results.
Will taking part affect my cataract surgery?
The study aims to fit in with your planned cataract surgery. The collection of the fluid sample happens during the surgery itself and is a very common part of the procedure. It should not change how your surgery is performed or its outcome.
Do I get paid to participate?
The study information provided here doesn't mention payment. It's best to ask the study team directly if there is any reimbursement for your time or travel expenses.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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