Status:
RECRUITING
Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)
Lead Sponsor:
Agnes
Collaborating Sponsors:
Direction Générale de l'Offre de Soins
Laboratoires Thea
Conditions:
Ocular Inflammation
Ocular Prostheses
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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.
Detailed Description
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 prop...
Eligibility 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.
Key Trial Info
Start Date :
May 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 20 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05668455
Start Date
May 12 2023
End Date
July 20 2026
Last Update
August 15 2025
Active Locations (1)
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1
Centre Hospitalier Universitaire de Rennes _ Pontchaillou
Rennes, France, 35000