drugset / Trial / NCT07671222
Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Infliximab | Monoclonal antibody | 1 mg/ml | Topical |
| Comparator | Loteprednol | Other / unclassified | 0.5 % | Topical |