Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients W
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.
| Condition(s) | Ocular Inflammation, Ocular Prostheses |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 treatm |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Agnes |
| Locations | Rennes, France |
| Start date | 2023-05-12 |
| NCT ID | NCT05668455 |
| Official listing | https://clinicaltrials.gov/study/NCT05668455 |