Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease

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.

NCT Number	NCT07671222
Lead Sponsor	Instituto de Oftalmología Fundación Conde de Valenciana
Conditions	Sjogren Syndrome, Sjogren Syndrome With Keratoconjunctivitis, Dry Eye Disease (DED)
Enrollment	38 participants
Start Date	2026-12
Primary Completion	2028-03 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-06-26