Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Recombinant Human Nerve Growth Factor Eye Drop Solution in Participants With Persistent Corneal Epithelial Defect (PCED)
This study is testing a new eye drop solution called OXERVATE (or a similar version) to see how well and how safely it helps heal a condition called Persistent Corneal Epithelial Defect (PCED). PCED means you have a wound on the surface of your eye that isn't healing properly. Researchers want to find out if using these eye drops can help the wound close completely within four weeks and stay healed for at least eight weeks. The study also compares this new treatment to a 'vehicle' which is like a dummy treatment that looks the same but doesn't contain the active medicine. This helps scientists understand if the new drops are truly effective.
At a glance
What is this study about?
Imagine the front surface of your eye, called the cornea, like a clear window. Sometimes, for different reasons, a small wound can appear on this window. Normally, these wounds heal quite quickly. However, in some people, these wounds don't heal, and they become a condition called Persistent Corneal Epithelial Defect, or PCED.
This study is a big, important trial, known as a Phase 3 study. It's designed to see if a special eye drop solution, which contains a protein called recombinant human Nerve Growth Factor (rhNGF), can help these persistent wounds heal. Nerve Growth Factor is a natural substance in your body that helps with healing and nerve repair.
By comparing the new eye drops (OXERVATE or a similar version) with a 'vehicle' (a drop that looks the same but doesn't have the active ingredient), the researchers can understand if the new drops are truly making a difference. The main goal is to see if the eye wound heals completely within 4 weeks and stays healed for 8 weeks. They will also measure how much the wound shrinks over time. This research is crucial to find better ways to treat PCED and improve people's eye health.
Key takeaways
- This study is for adults with persistent eye wounds (PCED).
- It tests new eye drops to help healing.
- You won't know if you get the new drug or a dummy treatment.
- Regular eye checks are part of the study.
- The aim is to see if the eye wound heals and stays healed.
Who may be eligible?
To be able to take part in this study, you need to be an adult, aged 18 years or older, with a diagnosis of Persistent Corneal Epithelial Defect (PCED). Both men and women can participate.
There might be other specific health requirements or conditions that mean you can or cannot join the study. These are put in place to ensure the study is safe for you and that the results are clear and accurate. For example, certain other eye conditions or medicines you are taking might affect whether you can participate.
If you are interested, a study doctor or nurse will check your medical history and perform some tests to see if the study is right for you. They will explain everything clearly.
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 a Persistent Corneal Epithelial Defect (PCED)?
- Are you comfortable attending regular eye clinic appointments?
- Are you willing to use eye drops as instructed for several weeks?
- Do you understand that you might receive a dummy treatment?
What does participation involve?
If you decide to take part, you would be given one of the eye drop solutions (either the new treatment or the 'vehicle' dummy treatment) to use regularly. This study is 'double-masked,' which means neither you nor your doctor will know which treatment you are receiving until after the study is complete. This helps to keep the results fair and unbiased.
You would have regular visits to the clinic over several weeks. During these visits, the study team would examine your eye to check how the wound is healing, measure its size, and make sure you are not experiencing any problems. They might also ask you about your symptoms and overall well-being. These check-ups are important to monitor your progress and ensure your safety. The total duration of your involvement could be several weeks or a few months, including follow-up appointments.
Potential risks and benefits
Locations (8)
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- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedFrance
Common questions
What is PCED?
PCED is a wound on the front surface of your eye (cornea) that doesn't heal on its own for a long time.
What are 'eye drops' in this study?
The study is testing new eye drops that contain a natural helper protein designed to mend eye wounds.
What does 'double-masked' mean?
It means neither you nor your study doctor will know whether you're getting the active drug or a dummy treatment until after the study.
Will I have to pay to join?
No, treatments and study-related visits in clinical trials are usually provided free of charge.
How long will I be involved?
The main part of the study involves treatment and checks over several weeks, with follow-up.
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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