A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Descemetorhexis in Subjects with Fuchs Endothelial Corneal Dystrophy
This research study is testing a new eye drop called Ripasudil for people who have Fuchs Endothelial Corneal Dystrophy and have recently had an eye operation called descemetorhexis. Fuchs Dystrophy affects the front window of your eye (the cornea), causing blurry vision. The operation aims to improve this. The study will compare Ripasudil eye drops to a dummy eye drop (placebo) to see if Ripasudil helps vision get better faster and more effectively after the operation. Researchers will also be checking how safe the eye drops are. This is a "Phase 3" study, which means it’s one of the final steps before a new treatment might become widely available.
At a glance
What is this study about?
This research study is about a new eye drop called Ripasudil. It's being tested for people who have an eye condition called Fuchs Endothelial Corneal Dystrophy. In this condition, cells at the back of the cornea (the clear front part of your eye) don't work properly, leading to swelling and blurry vision. The study focuses on patients who have recently had a specific eye operation called descemetorhexis, which involves removing the faulty cells to allow healthier ones to grow.
The main goal of this study is to find out if Ripasudil eye drops can help improve vision more quickly and effectively after this operation, compared to using a dummy eye drop (a placebo). We're particularly interested in how long it takes for a person's vision to improve significantly. We'll also be carefully checking for any side effects to make sure the drops are safe to use.
This is a "Phase 3" study, which means it’s a large and important step. It's designed to confirm the safety and effectiveness of Ripasudil before it can potentially be approved for general use. The study will last for about a year, including the period where the drops are used and a follow-up time to see the long-term effects.
Key takeaways
- This study is testing new eye drops (Ripasudil) for Fuchs Endothelial Corneal Dystrophy.
- It's for people who have recently had descemetorhexis eye surgery.
- The aim is to see if the drops help vision improve faster and safely.
- Participants will use the drops for 12 weeks, followed by a long follow-up period.
- This is a 'Phase 3' study, an important step in developing new treatments.
Who may be eligible?
To be part of this study, you would need to be 18 years old or older. Both men and women can take part.
However, there will be other specific health requirements that only your eye doctor (ophthalmologist) can check. These might include how well you can see currently, the specific details of your Fuchs Dystrophy, and whether you've had the descemetorhexis operation recently.
Your eye doctor will carefully review your medical history and perform some detailed eye exams to make sure this study is right for you and that you meet all the necessary criteria. It's important that you discuss all your health conditions and any medications you take with them.
- Are you 18 years old or older?
- Have you been diagnosed with Fuchs Endothelial Corneal Dystrophy?
- Have you recently had a descemetorhexis eye operation?
- Are you able to attend regular clinic visits for about a year?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will first have some detailed eye exams to make sure you are suitable. Then, you will be randomly assigned to either receive the Ripasudil eye drops or a dummy eye drop (placebo). Neither you nor your study doctor will know which drops you are receiving. You will use these drops for 12 weeks.
During these 12 weeks, you will have regular visits to the clinic for eye checks and vision tests to see how your eyes are responding. After 12 weeks, you will gradually stop using the drops over a two-week period. Following this, there will be a longer follow-up period of 38 weeks, during which you'll have further check-ups to monitor your eye health and vision progress. The total duration of your involvement in the study, including the follow-up, will be about a year.
Potential risks and benefits
Locations (3)
- —Denmark
- —Spain
- —Germany
Common questions
What is Fuchs Endothelial Corneal Dystrophy?
It's an eye condition where cells at the back of your cornea (the clear front part of your eye) don't work properly, causing swelling and blurry vision.
What is descemetorhexis?
It's a type of eye operation for Fuchs Dystrophy where the unhealthy cells at the back of the cornea are removed to help new, healthy cells grow.
What does 'double-masked' mean in a study?
It means neither you nor your study doctor will know if you are receiving the active eye drops or the dummy (placebo) drops. This helps make the study results fair.
How long will I be in the study?
The study involves using eye drops for 12 weeks, a two-week period to gradually stop them, and then a 38-week follow-up, so about one year in total.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time, for any reason, without affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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