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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

7 criteria

  • 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.
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Verified sites

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  • Verified

    Amsterdam UMC

    The NetherlandsAmsterdam, The Netherlands

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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.

What is already known about the treatment

  • Vitamin A ointment

    This medication is applied directly to the eye socket as an ointment to help alleviate chronic discomfort and discharge in individuals with artificial eyes. It is currently being studied for its effectiveness in reducing irritation and excess discharge in these patients. The main therapeutic use is to soothe and heal the eye socket area. At the molecular level, vitamin A supports the health of the skin and mucous membranes, promoting healing and reducing inflammation. It is classified as a vitamin supplement with potential therapeutic benefits for eye health.

  • Low-dose steroids

    Administered as eye drops, low-dose steroids are used to reduce inflammation and discomfort in the eye socket for those with artificial eyes. This medication is being evaluated for its ability to decrease chronic irritation and discharge. Its primary therapeutic role is to calm inflammation and provide relief from discomfort. Steroids work by suppressing the immune response and reducing inflammation at the molecular level. They are classified as anti-inflammatory agents.

  • Artificial tears

    These are eye drops used to lubricate the eye socket and provide relief from dryness and irritation for individuals with artificial eyes. The current study is assessing their effectiveness in managing chronic discharge and discomfort. The main therapeutic indication is to mimic natural tears, providing moisture and comfort to the eye area. Artificial tears work by forming a protective film over the eye surface, reducing friction and irritation. They are classified as ocular lubricants.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504451-27-01Estimated enrolment40 patientsSponsorAmsterdam UMC Stichting

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).