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 Simultaneous Cataract Surgery and Descemetorhexis in Subjects with Fuchs Endothelial Corneal Dystrophy
This research study is for people who have an eye condition called Fuchs Endothelial Corneal Dystrophy. After you have cataract surgery and another eye procedure called Descemetorhexis, doctors want to see if special eye drops, called Ripasudil, can help improve your vision. Some people will get the active eye drops, and others will get drops that look the same but don't contain the medicine (a placebo). This helps researchers understand if the new drops are truly effective. The study will look at how quickly your vision improves over 12 weeks and then follow you for a longer period to ensure safety and lasting effects. This is a crucial step to see if these drops could be a new treatment option.
At a glance
What is this study about?
This study is designed for individuals who have a specific eye condition called Fuchs Endothelial Corneal Dystrophy. This condition affects the clear front window of your eye, called the cornea, and can make your vision blurry. People taking part in this study will also be having two types of eye surgery at the same time: cataract surgery (to replace a cloudy lens) and a procedure called Descemetorhexis, which helps to improve the cornea.
The main goal of the study is to find out if new eye drops, called Ripasudil, can help people see better and recover more quickly after these operations. To do this, the study will compare Ripasudil eye drops with a 'placebo' – these are eye drops that look exactly the same but don't contain the active medicine. This comparison is very important because it helps doctors understand if any improvement you experience is truly due to the new eye drops or if it would have happened anyway.
Researchers will closely monitor how your vision changes over 12 weeks after surgery, looking for significant improvements in your eyesight. They will also follow up with you for about a year to check on your overall eye health and see how well the eye drops are tolerated. This kind of study is a big step towards potentially providing new and better treatments for people with Fuchs Endothelial Corneal Dystrophy.
Key takeaways
- New eye drops for Fuchs Endothelial Corneal Dystrophy.
- Aims to improve vision after specific eye surgeries.
- Compares Ripasudil to non-medicated (placebo) drops.
- Involves 12 weeks of drop use, followed by monitoring.
- Study lasts around one year in total.
- Participants must be 18+ with Fuchs and planned surgeries.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older, and can be any gender. The most important requirement is that you have been diagnosed with Fuchs Endothelial Corneal Dystrophy and are preparing to have specific eye surgeries.
Doctors will carefully check your overall health and your specific eye condition to make sure this study is right for you. They will explain all the details and make sure you understand what's involved before deciding if you can join. Your safety is always the top priority.
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?
- Have you been diagnosed with Fuchs Endothelial Corneal Dystrophy?
- Are you scheduled for cataract surgery and Descemetorhexis at the same time?
- Are you generally in good health and able to attend regular clinic visits?
What does participation involve?
If you decide to take part in this study, you would receive either the Ripasudil eye drops or a placebo (which look identical but contain no medicine). You would use these drops for 12 weeks. During this time, you would have regular visits to the clinic so doctors can check your vision and eye health very carefully. These checks will include measuring how well you can read an eye chart.
After the 12 weeks of using the drops, there will be a two-week period where the amount of drops you use is gradually reduced. Following this, you will enter a longer follow-up phase lasting about 38 weeks, where doctors will continue to monitor your eyesight and general eye health without the direct study medication. The total time you would be involved in the study from start to finish would be around one year.
Potential risks and benefits
Locations (3)
- —UnverifiedGermany
- —UnverifiedDenmark
- —UnverifiedSpain
Common questions
What is Fuchs Endothelial Corneal Dystrophy?
It's an eye condition that affects the clear front part of your eye (cornea), making it swell and leading to blurry vision.
What are 'placebo' eye drops?
These are drops that look exactly like the study medicine but don't contain any active drug. They help researchers compare the new medicine's effects.
How long will I be in the study?
The study lasts for about a year in total, including 12 weeks of using the drops, a short tapering period, and a longer follow-up.
Will I know if I'm getting the real medicine?
No, neither you nor your doctors involved in your care will know if you're getting the active drops or the placebo. This is to keep the study fair and accurate.
What if I don't want to continue in the study?
You are free to leave the study at any time, for any reason. Your decision will not affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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