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Comparison of hydrocortisone and dexamethasone eye drops for treating inflammatory conjunctival secretions in patients with ocular prostheses

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What is this trial about?

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

This study focuses on treating inflammatory secretions of the conjunctiva in patients who wear artificial eyes (ocular prostheses). The condition involves inflammation and discharge from the tissue lining the eye socket where the prosthetic eye is placed. The study compares three different eye drop solutions: Dexafree (containing dexamethasone), Softacort (containing hydrocortisone), and Dulcilarmes (containing povidone, a tear substitute).

The purpose of this research is to evaluate how well two different anti-inflammatory medications work compared to artificial tears in managing secretions in patients with eye prostheses. The medications being tested are steroids that help reduce inflammation when applied directly to the eye area. The treatment involves using eye drops for a period of 14 days.

During the study, participants will receive one of the three eye drop solutions. The study will monitor changes in the amount, color, and consistency of eye secretions, as well as the level of inflammation in the eye socket tissue. The research will also track how these treatments affect the daily comfort and quality of life of people who wear artificial eyes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eye secretions and conjunctival inflammation will be evaluated using specific scoring systems

    You will complete a quality of life questionnaire about your experience with the ocular prosthesis

    Your current symptoms will be documented using a secretion self-rating scale

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive one of three eye drop solutions:

    - Dexafree (dexamethasone) 1 mg/ml eye drops

    - Softacort (hydrocortisone) 3.35 mg/ml eye drops

    - Dulcilarmes (artificial tears) 1.5% eye drops

  3. Step 3

    Treatment period

    You will apply the assigned eye drops to the area around your prosthesis

    The treatment will be administered through topical application

    Regular evaluations will track changes in your eye secretions and inflammation

  4. Step 4

    Monitoring and assessment

    Your progress will be monitored using several measures:

    - Secretion characteristics (frequency, color, amount, and thickness)

    - Conjunctival inflammation levels

    - Impact on your daily activities and comfort with the prosthesis

  5. Step 5

    Final evaluation

    The study will assess the effectiveness of the treatments by comparing:

    - Changes in secretion patterns

    - Reduction in inflammation

    - Improvements in your quality of life scores

    The study duration extends until June 2026

Who can join the trial?

7 criteria

  • Must be 18 years or older
  • Must have been wearing an eye prosthesis (artificial eye) for more than 6 months
  • Must have a Modified OSDI score of 13 or higher out of 40 (OSDI is a questionnaire that measures eye discomfort symptoms)
  • Must be registered with a health insurance scheme
  • Must be able to provide written informed consent (formal agreement to participate in the study)
  • Must be under the care of an ophthalmology department (eye specialist department)
  • Both men and women can participate

Who cannot join the trial?

10 criteria

  • Persons under the age of 18 years old cannot participate in the study
  • Patients with known allergies to any components of the study medications (Hydrocortisone, Dexamethasone, or DULCILARMES®)
  • Patients with active eye infections (such as bacterial or viral conjunctivitis)
  • People who are currently participating in other clinical trials
  • Patients who have had eye surgery within the last 3 months
  • Individuals with uncontrolled systemic diseases (such as diabetes or high blood pressure)
  • Pregnant or breastfeeding women
  • Patients using other eye medications that could interfere with the study
  • Individuals who cannot follow the study protocol or attend scheduled visits
  • People with severe dry eye syndrome requiring additional treatments
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Investigated drugs

  • Hydrocortisone

    is a topical steroid eye medication that helps reduce inflammation and irritation in the eye socket of patients who wear ocular prostheses (artificial eyes). It works by suppressing the immune system's response that causes inflammation and excess secretions.

  • Dexamethasone

    is also a topical steroid eye medication that reduces inflammation and irritation. It is generally considered more potent than hydrocortisone and is commonly used to treat various eye conditions involving inflammation.

  • Dulcilarmes

    is an artificial tear solution that helps lubricate the eye socket and prosthesis. It acts as a tear substitute to provide moisture and comfort for patients with ocular prostheses. In this trial, it serves as a comparison treatment to evaluate the effectiveness of the steroid medications.

What is already known about the treatment

  • Hydrocortisone

    A topical corticosteroid medication administered in the form of eye drops for treating inflammatory conditions of the eye. This well-established anti-inflammatory agent works by suppressing the immune response and reducing inflammation in the conjunctiva, making it particularly useful for patients with ocular prostheses who experience inflammatory secretions. It acts by blocking the production of inflammatory chemicals in the body at the molecular level, belonging to the glucocorticoid class of medications.

  • Dexamethasone

    A potent synthetic corticosteroid delivered as eye drops, commonly used in ophthalmology for treating various inflammatory eye conditions. This medication works by reducing inflammation and suppressing immune responses in the eye tissue, particularly effective for managing inflammatory secretions in patients with ocular prostheses. At the molecular level, it inhibits inflammatory mediators and reduces swelling, belonging to the glucocorticoid class of medications with stronger anti-inflammatory properties compared to hydrocortisone.

  • Dulcilarmes

    An artificial tear substitute used as a comparator in treating eye conditions, specifically formulated to provide lubrication and comfort for dry or irritated eyes. This solution helps maintain proper eye moisture and reduces discomfort in patients with ocular prostheses by mimicking natural tears. It belongs to the class of artificial tear preparations and acts primarily by providing mechanical lubrication and moisture to the eye surface.

Investigated diseases

  • Conjunctivitis

    A condition where the conjunctiva, the clear tissue covering the white part of the eye and inner eyelid, becomes inflamed and produces excessive secretions. The inflammation causes the eyes to become red, swollen, and produces varying amounts of discharge that can range from watery to thick. The secretions can vary in color and consistency, affecting the comfort of the eye and potentially interfering with vision. In cases involving eye prostheses, the condition can cause particular discomfort and requires special attention to the socket area.

  • Inflammatory Eye Disease

    A condition characterized by inflammation of various parts of the eye tissue, particularly affecting the conjunctiva and surrounding areas. The condition typically manifests with increased secretion production, redness, and discomfort in the affected area. The inflammatory process can lead to changes in the quantity and quality of eye secretions, ranging from thin and watery to thick and viscous. This condition can particularly affect individuals with prosthetic eyes, causing specific challenges in the prosthesis-bearing socket.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517441-14-00Protocol code35RC21_8901Estimated enrolment30 patientsSponsorCentre Hospitalier Universitaire De Rennes

sourced from the EU Clinical Trials Register and site verification

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