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Safety and Efficacy of Topical Infliximab Versus Topical Steroid in Autoimmune Dry Eye Disease
NCT07671222Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Dec 2026
- Primary completion
- Mar 2028
- Countries
- 1
- Sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Drugs
- infliximab
- Conditions
- dry eye disease (DED)Sjögren's syndrome
01
Overview
Phase 2, randomised trial in dry eye disease (DED) and Sjögren's syndrome comparing Infliximab group with Vehicle group (2 arms). Primary endpoint: Ocular Surface Disease Index at 6 weeks. Planned start Dec 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- Randomized
Infliximab group
Topical infliximab 0.1% + loteprednol 0.5%
Vehicle group
Vehicle (CMC 1%) + loteprednol 0.5%
03
Who it enrols
Adult patients with confirmed Sjögren's syndrome and severe dry eye disease (OSDI >= 33, OSS >= 6) on stable systemic immunomodulatory therapy, excluding those with active ocular infections, recent ocular surgery, or contraindications to infliximab.
04
Endpoints
Primary
Ocular Surface Disease Index
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