Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)
This study aims to find the best eye drops for people who wear artificial eyes and experience discomfort like sandy feelings or discharge. Many people with artificial eyes in France face these issues, and while various treatments exist, they haven't been thoroughly tested. This research will compare two medications, Hydrocortisone and Dexamethasone, in a careful study to see how well they relieve these symptoms. By doing this, we hope to find a more effective way to help patients with artificial eyes feel more comfortable. It's a new study designed to provide clear answers about these treatments.
At a glance
What is this study about?
If you wear an artificial eye, you might sometimes experience discomfort, a feeling like sand in your eye, or a sticky discharge. This can be quite bothersome. While there are some eye drops available, it’s not always clear which ones work best to ease these types of irritation. This means that doctors don't have strong scientific evidence to guide them on the most effective treatment for people like you.
This study, therefore, wants to change that. Researchers are looking at two types of anti-inflammatory eye drops, Hydrocortisone and Dexamethasone, which are already used for other eye conditions. They want to find out if these drops can effectively reduce the discomfort and discharge in people with artificial eyes, making their daily lives more comfortable. The aim is to get clear, scientific answers to help doctors choose the best treatment.
The study will involve a careful comparison, where participants will try both types of eye drops at different times. This 'cross-over design' helps researchers see which medication works better for each individual. By doing this, they hope to establish a clear recommendation for which eye drops are most helpful for people wearing artificial eyes, leading to better care and improved comfort.
Key takeaways
- Researchers are testing eye drops for discomfort with artificial eyes.
- The study compares Hydrocortisone and Dexamethasone eye drops.
- It aims to find the most effective treatment for irritation.
- Participants will try both active treatments and a placebo.
- The goal is to improve comfort for people with artificial eyes.
Who may be eligible?
To join this study, you need to be 18 years old or older and have been wearing your permanent artificial eye for at least six months. You should also be feeling a noticeable level of discomfort or irritation related to your artificial eye, which your eye doctor can assess. Women who could become pregnant will need to use effective birth control throughout the study timeframe.
There are also some reasons why you might not be able to join. For example, if you're already using other eye drops (apart from artificial tears or antiseptic drops) within the last month, or if you have certain medical conditions like a severely damaged artificial eye or a confirmed allergy to the study medications. If you are pregnant or breastfeeding, you also won't be able to participate. The study also cannot include individuals who might have difficulty understanding or completing the study tasks.
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 worn a permanent artificial eye for over 6 months?
- Do you experience significant discomfort or discharge from your artificial eye?
- Are you able to use contraception if you are a woman who could become pregnant?
- Are you not currently pregnant or breastfeeding?
- Are you not currently using other specific eye drops (other than artificial tears or antiseptic)?
What does participation involve?
Taking part in this study would involve different visits to your eye doctor over a period. You would use both study eye drops (Hydrocortisone and Dexamethasone), but at different times, so the researchers can compare them directly. You would also use a 'placebo' drop, which looks like the real medication but contains no active ingredient, to help doctors see if the treatments themselves are truly making a difference. During your appointments, the research team would assess your comfort levels and monitor any changes in your symptoms. The study will involve giving your informed consent in writing before you start.
Potential risks and benefits
Locations (1)
- Centre Hospitalier Universitaire de Rennes _ PontchaillouVerified postcodeRennes, France· Recruiting
Common questions
What kind of artificial eye do I need to have to join?
You need to have been wearing a permanent artificial eye for at least six months.
What if I'm already using other eye drops?
If you're using eye drops other than artificial tears or antiseptic drops within the last month, you might not be able to join.
Will I know if I'm getting the real medication or a dummy drop?
No, this is a 'single-blind' study, meaning you won't know if you're receiving the active medication or the placebo. This helps get accurate results.
How long will the study last?
The information doesn't specify the exact total duration, but it involves multiple visits and using different eye drops over time.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time without giving a reason, and it won't affect your medical care.
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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