Study Comparing Hydrocortisone and Dexamethasone Eye Drops for Inflammation in Patients with Eye Prostheses

What this Trial Is About

Researchers are studying the effects of two topical corticosteroid treatments, Hydrocortisone and Dexamethasone, in adults who wear ocular prostheses and experience significant discomfort from inflammatory secretions. This trial aims to determine the value of these anti-inflammatory treatments compared to a placebo in reducing symptoms and improving comfort for these patients. The study is a prospective, randomized, single-blind clinical trial designed to provide controlled evidence for treatment effectiveness. Participants will receive three different treatments in a cross-over design Hydrocortisone eye drops, Dexamethasone eye drops, and a tear substitute Povidone used as a placebo. Each treatment period lasts 14 days, separated by one-month wash-out phases. The treatments are administered as one drop four times a day. This design allows each participant to receive all treatments in sequence, helping compare their effects individually. During the study, participants will be evaluated at multiple time points before, during, and after each treatment phase. Researchers will use self-rating scales to measure secretion symptoms and assess conjunctival inflammation through clinical scores. They will also monitor secretion frequency, color, amount, and viscosity, as well as quality of life using a specific questionnaire adapted for prosthesis wearers. The total study duration per participant is about 3.5 months, including treatment and wash-out periods, with regular visits for assessments and monitoring.

Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)