Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)
Recruiting now · Phase 3
Conditions studied: Ocular Inflammation, Ocular Prostheses
In brief
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.
Key facts
- Study ID
- NCT05668455
- Run by
- Agnes
- People needed
- 30
- Starts
- 2023-05-12
- Expected to finish
- 2026-07-20
- Last updated by the study team
- 2025-08-15
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Centre Hospitalier Universitaire de Rennes _ Pontchaillou — Rennes, France (enrolling)
Full record on ClinicalTrials.gov
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