Study on Reducing Eye Prosthesis Discomfort and Discharge Using Retinol Palmitate, Sodium Hyaluronate, and Fluorometholone for Patients with Chronic Symptoms

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What is this study about?

This clinical trial is focused on helping people who wear an artificial eye and experience ongoing issues with irritation or excessive discharge from the eye socket. The study is examining the effects of three different treatments: artificial tears, vitamin A ointment (known as Retinol Palmitate), and low-dose steroid drops (specifically Fluorometholone). These treatments are being tested to see how well they can reduce discomfort and discharge in individuals with these chronic symptoms.

The purpose of the study is to compare the effectiveness of these treatments in relieving symptoms. Participants will be randomly assigned to use one of the treatments for a period of two weeks. During this time, they will report any changes in their symptoms, such as discomfort and discharge levels. The study aims to identify which treatment works best for different individuals and to understand more about the characteristics of patients who benefit from each treatment.

Participants will use their assigned treatment as directed, and their progress will be monitored throughout the study. The goal is to find the most effective way to manage symptoms for those who wear an artificial eye and experience chronic irritation or discharge. This research could lead to better treatment options and improved quality of life for individuals with these conditions.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. The study aims to test the effect of different eye treatments for those wearing an artificial eye and experiencing chronic irritation or excess discharge.

2 initial assessment

An initial assessment will be conducted to evaluate your current level of discomfort and discharge. This will serve as a baseline to measure any changes during the study.

3 treatment allocation

You will be randomly assigned to one of three treatment groups: artificial tears, vitamin A ointment, or low-dose steroid drops. This is to compare the effectiveness of each treatment.

4 treatment administration

If assigned to the artificial tears group, you will use eye drops containing sodium hyaluronate, carbomer 981 as needed for relief.

If assigned to the vitamin A ointment group, you will apply retinol palmitate ointment to the affected area as directed.

If assigned to the low-dose steroid drops group, you will use fluorometholone eye drops as prescribed.

The treatment will last for a period of two weeks.

5 follow-up assessment

After two weeks of treatment, a follow-up assessment will be conducted to evaluate any changes in your discomfort and discharge levels. This will help determine the effectiveness of the treatment you received.

6 completion of study

Upon completion of the study, the results will be analyzed to identify which treatment is most beneficial for patients with similar conditions.

Who Can Join the Study?

Must be wearing an ocular prosthesis (an artificial eye).
Experiencing excess mucopurulent discharge (thick, mucus-like fluid) and/or discomfort in the eye socket.
Open to both male and female participants.
Participants of all ages are welcome.

Who Cannot Join the Study?

Patients with any other eye condition that could interfere with the study results.
Patients who have had recent eye surgery or plan to have eye surgery during the study period.
Patients who are currently using other eye medications that cannot be stopped for the study.
Patients with a known allergy to any of the study medications, such as artificial tears, vitamin A ointment, or steroid drops.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend the required study visits.
Patients with a history of non-compliance in previous clinical studies.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Asnqqqnjb Upy	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.09.2023

Trial locations

Investigated drugs:

Vitamin A Ointment is a type of cream that is applied to the skin or, in this case, the area around the eye socket. It is used to help soothe and heal the skin, reducing irritation and discomfort. In this trial, it is being tested to see if it can help people who wear artificial eyes and experience chronic irritation or excess discharge.

Low-Dose Steroids are medications that help reduce inflammation and irritation. They are often used to treat various conditions where swelling and irritation are a problem. In this trial, steroid drops are being tested to see if they can help reduce the discomfort and discharge experienced by people who wear artificial eyes.

Artificial Tears are eye drops that mimic the natural tears produced by your eyes. They are used to keep the eyes moist and comfortable, especially when they feel dry or irritated. In this trial, artificial tears are being tested to see if they can help alleviate the symptoms of irritation and discharge in people who wear artificial eyes.

Investigated diseases:

Eye disorder

Chronic mucopurulent discharge and discomfort of the ocular prosthesis socket – This condition involves persistent discharge and irritation in the socket where an artificial eye is placed. The discharge is typically a mix of mucus and pus, indicating ongoing inflammation or irritation. Individuals with this condition often experience discomfort, which can include itching, redness, or a gritty sensation in the socket. The condition progresses as the discharge and discomfort persist, potentially leading to increased irritation and inflammation. Over time, the socket may become more sensitive, and the frequency or volume of discharge may increase. The condition requires ongoing management to alleviate symptoms and prevent further irritation.

Trial ID:

2023-504451-27-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Reducing Eye Prosthesis Discomfort and Discharge Using Retinol Palmitate, Sodium Hyaluronate, and Fluorometholone for Patients with Chronic Symptoms

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?