MULTICENTRE, RANDOMISED, DOUBLE-BLIND, VEHICLE AND ACTIVE-CONTROLLED PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML COMPARED TO VEHICLE AND KETOFTIL (KETOTIFEN OPHTHALMIC SOLUTION 0.5 MG/ML) FOR THE TREATMENT OF SEASONAL ALLERGIC CONJUNCTIVITIS.
This research trial is testing a new eye drop called Ketotifen for people who get itchy eyes due to seasonal allergies, like hay fever. We want to see if this new eye drop is effective and safe. The study compares it to an existing eye drop of the same type (Ketoftil) and a dummy drop (placebo) that contains no active medicine. Participants will use one of these drops, and we will carefully check how much their eyes itch, as well as looking for other symptoms like redness and swelling. The study will last for 14 days and is for adults aged 18 and over.
At a glance
What is this study about?
This study is designed to understand if a new eye drop, called Ketotifen, can help people who suffer from itchy eyes because of seasonal allergies – things like hay fever that make your eyes watery and uncomfortable at certain times of the year. Many people experience this, and we're looking for ways to make it better. The study aims to find out how well Ketotifen works and if it causes any side effects.
To do this, we'll be comparing Ketotifen to two other things. One is an existing eye drop called Ketoftil, which contains the same active ingredient. The other is a 'dummy' eye drop, which looks exactly the same but doesn't contain any medicine – this is called a placebo. By comparing all three, we can clearly see if Ketotifen truly makes a difference and if it's better or just as good as what's already available.
The main thing we're checking is how much your eyes itch after using the drops. We'll also look at other symptoms like redness, swelling, and watering of the eyes. This helps us get a full picture of how the eye drops are working. The study is very carefully designed with strict rules to make sure we get reliable information, which is important for developing new medicines.
Key takeaways
- This study tests a new eye drop for seasonal itchy eyes.
- It compares the new drop to an existing one and a dummy drop.
- The main goal is to see if the new drop reduces eye itching.
- It will also check for other symptoms like redness and swelling.
- The study lasts for 14 days for adults 18 and over.
- Participants will not know which eye drop they are receiving.
Who may be eligible?
This study is open to adults aged 18 and over, both men and women. To make sure the results are helpful for people with seasonal allergies, we are looking for individuals who regularly experience itchy eyes during specific seasons, often due to things like pollen.
Before you can join, doctors will check your general health and your eyes to make sure that taking part in the study is right for you. They will need to confirm that your itchy eyes are indeed caused by seasonal allergies and not by another eye condition that might affect the study results. They'll also make sure you don't have any health issues that would make using the study eye drops unsafe 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?
- Do you get itchy eyes specifically during certain seasons (like hay fever season)?
- Are you able to attend several short appointments over a 14-day period?
- Do you feel comfortable using eye drops?
- Are you generally in good health?
- Are you happy for doctors to check your eyes regularly?
What does participation involve?
If you decide to take part in this study, you'll be given one of three types of eye drops: experimental Ketotifen, standard Ketoftil, or a dummy (placebo) drop. You won't know which one you're getting, and neither will the study doctors – this helps to keep the results fair and accurate. You'll use these drops in your eyes as instructed for 14 days.
During this time, you'll have several appointments. The first visit will be to check if you're suitable for the study. After you start using the drops, you'll have follow-up visits at 30 minutes, 2 days, 7 days, and 14 days after your first dose. At each visit, you'll be asked to rate how much your eyes itch using a simple scale. The study doctors will also carefully check your eyes for things like redness, swelling, and any other changes. They'll also ask you about any side effects you might experience. The total duration of your active participation, using the drops and attending appointments, will be about 14 days.
Potential risks and benefits
Locations (1)
- —UnverifiedItaly
Common questions
What are 'seasonal allergic conjunctivitis' eye drops?
These are eye drops used to treat itchy, watery, and red eyes that happen at certain times of the year due to allergies, like hay fever.
What does 'double-blind' mean in a study?
It means neither you nor the doctors treating you will know if you're getting the new eye drops, the existing ones, or the dummy drops. This ensures fair and unbiased results.
What is a 'placebo'?
A placebo is a 'dummy' eye drop that looks like the real medicine but contains no active ingredients. It helps us see if the medicine itself is causing any effects, rather than just the act of using eye drops.
How long will I be in the study?
If you join, you will be in the study for about 14 days, including using the eye drops and attending follow-up appointments.
Will I have to pay to be part of this study?
No, you will not have to pay to participate in this research study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.