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Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease

NCT07671222 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-06-26

No results posted yet for this study

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.

Conditions

  • Sjogren Syndrome
  • Sjogren Syndrome With Keratoconjunctivitis
  • Dry Eye Disease (DED)

Interventions

DRUG

Infliximab 0.1%

It uses topical infliximab at 1 mg/mL (0.1%) formulated in preservative-free 1% carboxymethylcellulose (CMC), administered as 1 drop in each eye four times daily for 6 weeks. The comparator is an identical vehicle (CMC 1% without infliximab), which helps isolate the effect of infliximab itself.

DRUG

Loteprednol

The comparator is an identical vehicle (CMC 1% without infliximab), which helps isolate the effect of infliximab itself.

Sponsors & Collaborators

  • Instituto de Oftalmología Fundación Conde de Valenciana

    lead OTHER

Principal Investigators

  • Enrique Graue-Hernandez, MD, MSc · Instituto de Oftalmologia Fundacion Conde de Valenciana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07671222 on ClinicalTrials.gov