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Study on Reducing Eye Prosthesis Discomfort and Discharge Using Retinol Palmitate, Fluorometholone, and Artificial Tears for Patients with Chronic Eye Socket Issues

Verified siteRegistered drugNo placebo
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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 like irritation or too much discharge from the eye socket. The study is looking at three different treatments to see which one works best for these symptoms. The treatments being tested are artificial tears, vitamin A ointment, and steroid eye drops. The artificial tears are a type of eye drop that helps to keep the eye moist, the vitamin A ointment is a cream that contains a form of vitamin A known as retinol palmitate, and the steroid eye drops contain a medication called fluorometholone, which helps reduce inflammation.

The purpose of the study is to compare these treatments to find out which one is most effective in reducing discomfort and discharge for people with an artificial eye. Participants in the study will use one of these treatments for a period of two weeks. During this time, they will be asked to report any changes in their symptoms, such as how much discomfort or discharge they experience. This will help researchers understand which treatment provides the most relief.

By the end of the study, the goal is to identify which treatment works best for reducing symptoms in people with an artificial eye. This information could help improve the quality of life for those who experience these common issues. The study will also try to determine which types of patients benefit the most from each treatment option. This could lead to more personalized care for individuals with these symptoms.

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 ocular prosthesis and experiencing chronic discomfort or 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 and carbomer 981. If assigned to the vitamin A ointment group, you will use retinol palmitate. If assigned to the low-dose steroid drops group, you will use fluorometholone. All treatments are for ophthalmic use (applied to the eye).

    The specific dosage and frequency will be provided to you based on the group you are assigned to. 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 measure 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 understand which treatment is most beneficial for patients with similar conditions. Your participation will contribute to this understanding.

Who can join the trial?

5 criteria

  • Must be wearing an ocular prosthesis (an artificial eye).
  • Experiencing chronic mucopurulent discharge (long-term thick, sticky fluid) and/or discomfort in the eye socket.
  • Complaints of irritation and/or excess discharge from 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 might interfere with the study.
  • Patients who have had recent eye surgery.
  • Patients who are currently using other eye medications that could affect the study results.
  • 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 visits.
  • Patients with a history of non-compliance in previous clinical trials.
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Verified sites

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  • Amsterdam UMC

    Responsive

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

  • Vitamin A Ointment

    is a topical treatment applied to the surface of the eye. It is used to help soothe irritation and reduce discharge in people who wear artificial eyes. The ointment works by providing a protective layer over the eye, which can help to heal and protect the delicate tissues.

  • Low-Dose Steroids

    are eye drops that contain a small amount of steroid medication. These drops are used to reduce inflammation and irritation in the eye. By decreasing swelling and redness, they can help make the eye feel more comfortable and reduce the amount of discharge.

  • Artificial Tears

    are eye drops that mimic the natural moisture found in the eye. They are used to keep the eye lubricated, which can help relieve dryness and irritation. For people with artificial eyes, artificial tears can help maintain comfort and reduce the feeling of dryness or grittiness.

What is already known about the treatment

  • Vitamin A ointment

    This medication is applied directly to the eye socket as an ointment and is currently being studied for its effectiveness in reducing chronic discharge and discomfort in individuals with artificial eyes. It is known for its role in maintaining healthy skin and mucous membranes, which may help soothe irritation in the eye socket. Vitamin A works at the molecular level by promoting cell growth and repair, which can aid in 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 being tested for their ability to alleviate chronic irritation and discharge in the sockets of artificial eye wearers. These medications are well-documented in medical literature for their anti-inflammatory properties, which help reduce swelling and discomfort. At the molecular level, steroids work by inhibiting the production of substances that cause inflammation. They are classified as anti-inflammatory agents and are commonly used to treat various inflammatory conditions.

  • Artificial tears

    Delivered as eye drops, artificial tears are being evaluated for their effectiveness in relieving chronic discomfort and discharge in the eye sockets of individuals with prosthetic eyes. These drops are widely used in medicine to provide lubrication and moisture to the eyes, mimicking natural tears. They work by forming a protective film over the eye surface, reducing irritation and dryness. Artificial tears are classified as ocular lubricants and are a common remedy for dry eye symptoms.

Investigated diseases

Chronic mucopurulent discharge and discomfort of the ocular prosthesis socket – This condition involves persistent mucus and pus-like discharge from the socket where an artificial eye is placed. It often results in ongoing discomfort for the individual wearing the prosthesis. The discharge is typically due to inflammation or irritation of the socket tissue. Over time, this can lead to increased sensitivity and a feeling of irritation in the affected area. The condition may fluctuate, with periods of more intense symptoms followed by times of relative calm. It is a non-infectious issue, primarily related to the body's response to the prosthetic device.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504451-27-00Estimated enrolment100 patientsSponsorAmsterdam UMC Stichting

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