Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Treating socket discharge and discomfort: randomized test of vitamin A ointment, low-dose steroids and artificial tears

This research is testing treatments for people who use an artificial eye and experience ongoing discomfort or discharge (like watery or sticky eye). The study aims to find out if vitamin A ointment, a mild steroid called FML Liquifilm, or artificial tears are most effective in reducing these symptoms. Participants will use one of these treatments for two weeks, and scientists will observe how their discomfort and discharge levels change. The goal is to see which treatment helps people feel better and has less discharge from their artificial eye socket, ultimately helping doctors decide the best way to help patients with these issues.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Amsterdam UMC

Enrolment target

Start

09 Sep 2023

Chronic mucopurulent discharge and/or discomfort of the ocular prosthesis socket

What is this study about?

This study is for people who wear an artificial eye and have problems like regular stickiness, watering, or a feeling of discomfort in the eye socket. Sometimes, even with an artificial eye, people can experience these ongoing issues, which can be quite bothersome.

The research wants to compare three different treatments to see which one works best. These treatments are: a special vitamin A ointment (called Retinol Palmitate), a mild steroid eye drop (called FML Liquifilm 0.1%), and standard artificial eye drops (called Hylan 0.15%). The main point of the study is to measure how much someone's discomfort and discharge improve after using one of these treatments for two weeks.

By comparing these options, doctors hope to learn if one treatment is much better than the others for easing these symptoms. This information will help them give the best advice and care to people who wear artificial eyes and are experiencing these particular problems.

Key takeaways

This study is for adults with artificial eyes who have discomfort or discharge.
It compares vitamin A ointment, mild steroid eye drops, and artificial tears.
The main goal is to find out which treatment best reduces symptoms over two weeks.
Participation involves using one treatment for two weeks and having symptoms assessed.
This research aims to help doctors provide better care for people with artificial eyes.

Who may be eligible?

This study is looking for adults who are at least 18 years old. Both men and women are welcome to take part in this research.

The most important requirement is that you wear an artificial eye and are currently experiencing ongoing discomfort, stickiness, or discharge from the eye socket. This study is specifically designed to help people with these particular issues related to their artificial eye.

If you don't wear an artificial eye, or if you wear one but don't have these specific symptoms, then this study wouldn't be suitable for you.

Quick self-check

Are you 18 years old or older?
Do you wear an artificial eye?
Are you currently experiencing discomfort, stickiness, or discharge from your artificial eye socket?
Are you able to use eye drops or ointment as instructed for two weeks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be asked to use one of the three treatments (vitamin A ointment, mild steroid eye drops, or artificial eye drops) for a period of two weeks. You wouldn't get to choose which treatment you receive; it would be decided randomly, like flipping a coin.

Before you start, and after the two weeks of treatment, the study team would assess your level of discomfort and how much discharge you're experiencing from your artificial eye socket. This would involve answering some questions and possibly a simple examination. The total duration of your active participation, including assessments and using the medication, would be about two weeks.

Potential risks and benefits

Taking part in this study might offer you a potential benefit if one of the treatments helps to reduce your discomfort or discharge from your artificial eye socket. However, there's no guarantee that any of the treatments will work for you, and some people may not experience any improvement. As with any medication, there's always a small chance of side effects, although the treatments being tested are generally considered mild. The study team will explain any known potential side effects of the specific treatment you might receive. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Netherlands

Common questions

What is an 'artificial eye socket'?

It's the space where your artificial eye (also called a prosthetic eye) sits. Sometimes people experience problems in this area.

What does 'mucopurulent discharge' mean?

It's a medical way of saying a watery, sticky, or sometimes slightly thicker discharge coming from your eye socket. It can be a nuisance.

Are the treatments safe?

The treatments being studied (vitamin A ointment, mild steroid drops, and artificial tears) are generally well-known. Like all medicines, they can have side effects, but these are often mild. The study team will tell you more about the specific treatment you might receive.

Will I know which treatment I'm getting?

In this type of study, participants are usually randomly assigned to one of the treatments, and sometimes neither you nor the researchers know which one you are receiving until the end. This helps make the study as fair as possible.

How long will I be involved in the study?

Your active participation in the study, including using the treatment and having your symptoms checked, would last for about two weeks.