A 4-Week, Phase II, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel Group Study With 2 Weeks of Follow-Up to Evaluate Safety and Efficacy of Two Different Dosages of Isocyclosporin A Eye Drop Solution Versus Vehicle in Adult Patients with Atopic Keratoconjunctivitis (AKC).
This research is looking into a new eye drop called Isocyclosporin A, which could help adults suffering from Atopic Keratoconjunctivitis (AKC). AKC is a severe type of eye allergy that causes lots of discomfort. The study wants to find out if two different strengths of these eye drops can safely and effectively reduce symptoms like itchy eyes, compared to drops without any active medicine (a 'vehicle'). We'll track symptoms over four weeks, with a two-week follow-up, to understand how well the drops work and make sure they are safe for people to use.
At a glance
What is this study about?
This study is called a clinical trial, and it's looking for new ways to help people with a condition called Atopic Keratoconjunctivitis, often shortened to AKC. AKC is a severe form of eye allergy that can cause a lot of irritation and discomfort, including very itchy eyes, redness, and sometimes problems with vision. It's often linked to other allergic conditions like eczema or asthma.
The main goal of this particular study is to test a new eye drop solution containing a medicine called Isocyclosporin A. The researchers want to see if these new drops can make a real difference in reducing the key symptoms of AKC, especially how much the eyes itch. They're comparing two different strengths of the new eye drops against a 'vehicle' or 'dummy' drop, which looks exactly the same but doesn't contain any active medicine. This comparison helps doctors understand if the new medicine is truly effective.
By carefully watching how people's symptoms change over four weeks and then for another two weeks after that, the study aims to find out if the new drops are both effective and safe. They will also look at how comfortable the drops are to use and any potential side effects. This kind of research is really important for finding better treatments that can improve the quality of life for people living with AKC.
Key takeaways
- Testing new eye drops (Isocyclosporin A) for severe eye allergies (AKC).
- Aims to reduce itchy eyes and other symptoms.
- Compares two strengths of drops to a 'dummy' drop.
- Study lasts for 6 weeks (4 weeks treatment, 2 weeks follow-up).
- Open to adults aged 18 and over.
- Closely monitors safety and effectiveness.
Who may be eligible?
To join this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.
While the main criteria are simple, there will be other health requirements that you'll need to meet. For example, the doctors running the study will check your overall health and make sure taking part is safe for you. They'll also confirm you have a clear diagnosis of Atopic Keratoconjunctivitis (AKC).
If you have other serious health conditions or are taking certain medications, you might not be able to participate. It's really important to discuss your full medical history with the study team to see if this trial is right 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?
- Have you been diagnosed with Atopic Keratoconjunctivitis (AKC)?
- Are you able to attend several clinic visits over six weeks?
- Are you willing to use assigned eye drops daily for four weeks?
- Do you have any other serious health conditions that might prevent you from joining?
What does participation involve?
If you decide to take part in this study, you would be involved for a total of six weeks. During this time, you would receive eye drops to use every day. These drops would either contain one of two different doses of Isocyclosporin A or be a 'dummy' drop without any active medicine. Neither you nor the study team would know which drops you are receiving, to ensure the results are fair.
You would have several visits to the clinic over the six weeks. At these visits, doctors and nurses would carefully check your eyes, looking at things like redness, swelling, and any damage. They would also ask you to rate your symptoms, especially how much your eyes itch, using simple scales. Other assessments might include checking your vision, taking eye measurements, and asking questions about how your eye condition affects your daily life. Any side effects or discomfort from the drops would also be carefully recorded during these visits.
Potential risks and benefits
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Common questions
What is Atopic Keratoconjunctivitis (AKC)?
AKC is a severe eye allergy that causes very itchy, red, and irritated eyes, often linked to other allergies like eczema or asthma.
What kind of medication is being tested?
The study is testing new eye drops called Isocyclosporin A, in two different strengths, to see if they can reduce AKC symptoms.
Will I know if I'm getting the real medicine?
No, you won't know because the study is 'double-masked.' This means neither you nor the doctors will know if you're getting the active drug or the dummy drops.
How long will I be involved in the study?
Your involvement in the study will last for a total of six weeks, including a four-week treatment period and a two-week follow-up.
What is a 'dummy' drop?
A 'dummy' drop, also called a 'vehicle,' looks exactly like the active medicine but doesn't contain any drug. It helps compare the new treatment's real effects.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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