Overview

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

Status:
Not yet recruiting
Trial end date:
2025-02-20
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Agnes
Collaborators:
Direction Générale de l'Offre de Soins
Laboratoires Thea
Treatments:
Dexamethasone
Hydrocortisone
Povidone
Criteria
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.