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NCT05668455
Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)
Conditions: Ocular Inflammation, Ocular Prostheses
Sex: All
Ages: 18 Years – 85 Years
Phase: PHASE3
Enrollment: 30
Sponsor: Agnes
Location: France
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.
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 treatmentsDermal 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 studyPerson under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty.
Source: ClinicalTrials.gov (NCT05668455). StuddyBuddy aggregates publicly available trial information.