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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Rennes Rennes France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
12.05.2023

Trial locations

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.

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 ID:
2024-517441-14-00
Protocol code:
35RC21_8901
NCT ID:
NCT05668455
Trial Phase:
Human Pharmacology (Phase I) – Other

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