Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
This research study is looking at two different eye drop treatments, called BUFY01 and SVS20, for people who suffer from dry eye disease. The main goal is to find out if BUFY01 is as effective as SVS20 in helping to improve both the signs and symptoms of dry eye, like redness or irritation, and how your eyes feel. Patients who join will use one of the study eye drops daily for three months. They'll also visit the study clinic a few times for check-ups and to fill out questionnaires. This helps researchers understand which treatment works best and if it's safe for people to use.
At a glance
What is this study about?
Dry eye disease is a common condition where your eyes don't make enough tears, or the tears they do make aren't good quality. This can lead to your eyes feeling gritty, sore, or red. Finding effective ways to manage dry eye is really important for people's comfort and eye health. This study aims to compare a new potential treatment, BUFY01 eye drops, with an existing treatment, SVS20 eye drops. Both treatments come in single-use containers.
The researchers want to see if BUFY01 works just as well as SVS20 in improving the signs of dry eye that a doctor can see, and also in making your eyes feel better by reducing your symptoms. They're also carefully checking the safety of both treatments to make sure they don't cause any unexpected problems. By doing this comparison, they hope to get a clearer picture of how BUFY01 performs as a treatment option for dry eye.
This kind of study, where two treatments are compared, helps us understand which treatments are most helpful for patients. The information gathered will be valuable for doctors and patients when deciding on the best way to manage dry eye disease in the future. It’s part of the ongoing effort to improve healthcare for everyone.
Key takeaways
- This study compares two dry eye treatments: BUFY01 and SVS20 eye drops.
- The main aim is to see if BUFY01 works as well and is as safe as SVS20.
- Participation lasts about three months and includes clinic visits and using eye drops daily.
- It helps doctors understand the best ways to treat dry eye disease.
- You must be 18+ with dry eye disease and meet other health requirements.
Who may be eligible?
To join this study, you need to be at least 18 years old and have been diagnosed with dry eye disease in both eyes for at least three months. You should also be using artificial tears regularly for your dry eyes. Doctors will need to see certain signs of dry eye when they examine you, and you must have health insurance.
There are some reasons why you might not be able to join. For example, if you've recently started wearing contact lenses or if you have very poor vision. You also can't take part if you have certain other eye conditions like severe eyelid inflammation, allergies affecting your eyes, or if you've had eye surgery recently. If you're pregnant or breastfeeding, or if you've taken part in another research study in the last 90 days, you won't be able to participate. Also, if you've used certain eye drops with preservatives or other specific medications recently, you might not qualify.
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 at least 18 years old?
- Have you been diagnosed with dry eye disease in both eyes for at least 3 months?
- Do you regularly use artificial tears for your dry eyes?
- Have you *not* had eye surgery or severe eye irritation/infection recently?
- Are you *not* pregnant or breastfeeding?
- Have you *not* participated in another research study in the last 3 months?
What does participation involve?
If you join this study, you will be expected to visit the study clinic four times over a three-month period. During these visits, doctors will examine your eyes, and you will be asked to fill out several questionnaires about how your eyes feel. You will be given either BUFY01 or SVS20 eye drops to use every day throughout the three-month study period. It's important to use the drops as instructed. At the end of the study, you'll need to return any unused eye drops. The total duration of your active participation in the study will be approximately three months.
Potential risks and benefits
Locations (2)
- Hôpital des Quinze-VingtsVerified postcodeParis, France· Recruiting
- CHU Saint-EtienneVerified postcodeSaint-Priest-en-Jarez, France· Recruiting
Common questions
What is dry eye disease?
Dry eye disease is a condition where your eyes don't make enough tears, or the tears aren't good quality, leading to discomfort and irritation.
What are BUFY01 and SVS20?
These are the names of two different eye drop treatments being tested in this study for dry eye disease.
How long will the study last?
Your participation in the study will involve using eye drops daily and attending clinic visits over approximately three months.
Will I know which treatment I'm receiving?
Often in studies like this, you won't know which specific treatment you're receiving (BUFY01 or SVS20) to ensure the results are fair and unbiased.
Can I continue my other eye drops?
The study has specific rules about other eye drops you can or cannot use, especially those with preservatives, which the study team will explain.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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