Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)

Comparison of Topical Hydrocortisone Versus Dexamethasone Treatment for Inflammatory Secretions of the Conjonctiva in Patients With Ocular Prostheses

We propose to evaluate the efficacy of treatment with Hydrocortisone and Dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort.

There are more than 100,000 eye prosthesis wearers in France. Half of these patients are bothered by secretions or sandy sensations, or even chronic pain. Various anti-inflammatory treatments are proposed without scientific basis.

A pilot study on a limited number of patients conducted in 2017 at the University Hospital of Rennes and published in 2019 showed the interest of Dexamethasone eye drops in these patients. However, this study was retrospective and not controlled.

We therefore wish to propose a prospective, placebo-controlled, single-blind clinical study to define the value of anti-inflammatory treatment in patients with ocular prostheses.

We propose to evaluate the efficacy of treatment with Hydrocortisone and Dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort.

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.