Comparing treatments for inflammation in patients with eye prostheses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of Hydrocortisone and Dexamethasone in treating ocular inflammation in patients who wear ocular prostheses. It will utilize a prospective, placebo-controlled, single-blind design to assess the impact of these anti-inflammatory treatments on patients experiencing significant discomfort. The study builds on previous findings from a pilot study that suggested Dexamethasone may be beneficial, but seeks to provide more rigorous evidence through a controlled methodology.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient aged 18 years or older;
* Wearing a permanent prosthesis for more than 6 months; - Consultant in the ophthalmology department;
* Modified OSDI score ≥ 20 points out of 40 ;
* Affiliated with a health insurance scheme,
* For women of childbearing age: effective contraception (effective contraception includes oral contraception, intrauterine devices and other forms of contraception with a failure rate \<1%, for the duration of the study and up to 1 week after the last dose administered)
* Have given free, informed and written consent.

Exclusion Criteria:

* Treatment with eye drop(s) (other than artificial tears or antiseptic) \< 1 month;
* Concomitant treatment with CYP3A inhibitors including cobicistat containing drugs,
* Known contraindications to study treatments
* Dermal fat grafting or complicated cavity;
* Gougerot-Sjögren syndrome;
* Allergic conjunctivitis;
* Damaged prosthesis;
* Impossibility of carrying out the various tests required by the protocol for whatever reason (comprehension problems, motor disability);
* Pregnant or breastfeeding woman;
* Person already included in a RIPH1 research protocol with topical treatment of the cavity or systemic anti-inflammatory treatment and/or who could lead to a bias in the present study
* Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty.

Where it's running

• Centre Hospitalier Universitaire de Rennes _ Pontchaillou
  Rennes, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.