RecruitingPhase 3NCT05668455
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
Sponsor
Agnes
Enrollment
30 participants
Start Date
May 12, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria6
- 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 Criteria11
- 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.
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Interventions
DRUGHydrocortisone
1 drops 4 times a day
DRUGDexamethasone
1 drops 4 times a day
OTHERPovidone
1 drops 4 times a day
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05668455