drugset / Trial / NCT07671222

Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease

NCT07671222

Phase 2 Not yet recruiting 38 enrolled Instituto de Oftalmología Fundación Conde de Valenciana
RandomizedParallel-groupTriple-blindTreatment

Summary

Sjögren's syndrome is a condition in which the immune system attacks the body's moisture-producing glands. This often causes severe dry eye, leading to discomfort, irritation, blurred vision, and damage to the eye surface. Inflammation plays an important role in this process, and a protein called TNF-alpha is one of the key drivers. This study will test a new eye drop containing infliximab, a medication that blocks TNF-alpha. The goal is to see whether this treatment can safely improve symptoms and signs of severe dry eye in patients with Sjögren's syndrome.

Timeline

Start
2026-12
Primary completion
2028-03
Completion
2028-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 1 mg/ml Topical
Comparator Loteprednol Other / unclassified 0.5 % Topical