Menu
Not yet recruiting NCT07671222

Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease

Phase II Interventional Sjogren Syndrome Sjogren Syndrome With Keratoconjunctivitis Dry Eye Disease (DED)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Infliximab 0.1%, Loteprednol.
Who it may be relevant to
Registry conditions: Sjogren Syndrome, Sjogren Syndrome With Keratoconjunctivitis, Dry Eye Disease (DED). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Efficacy of Topical Infliximab Versus Topical Steroid in Autoimmune Dry Eye Disease: Randomized Controlled Trial.

Overview

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.

Detailed description

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.

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.

Primary outcome measures

  • Change in Ocular Surface Disease Index (OSDI) [Time frame: 6 weeks.]

Eligibility criteria

Inclusion criteria

  • Adult patients (≥ 18 years).
  • Confirmed diagnosis of primary or secondary Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria.
  • On stable systemic immunomodulatory therapy (non-biologic) for at least 12 weeks, with no planned changes during the study (see section 14.1 if there are concerns about confounding variables).
  • Negative chest X-ray or Interferon-Gamma Release Assays (IGRA).
  • Diagnosis of severe dry eye, defined by meeting all of the following criteria in at least one eye at study entry:
  • OSS (SICCA 0-12) ≥ 6 in at least one eye.
  • OSDI ≥ 33 (severe symptoms).
  • Symptoms: OSDI score ≥ 33.
  • Signs: Ocular Staining Score (OSS, SICCA) ≥ 6.
  • Ability to understand and sign informed consent and to comply with study procedures and treatment administration.

Exclusion criteria

  • Current use of topical corticosteroids or topical immunomodulators (cyclosporine, lifitegrast, tacrolimus, autologous serum) within 30 days prior to enrollment.
  • Current or recent use (< 3 months) of punctal plugs.
  • Active ocular infection (bacterial, viral, fungal) or recent history of herpetic keratitis.
  • Ocular or eyelid surgery within the past 6 months.
  • Use of contact lenses during the study period.
  • Known allergy or hypersensitivity to infliximab, murine proteins, or any component of the formulation (including CMC).
  • Coexisting ocular conditions that may interfere with dry eye evaluation (e.g., active ocular cicatricial pemphigoid, active ocular graft-versus-host disease, uncontrolled glaucoma, significant corneal dystrophy).
  • Systemic conditions considered contraindications to infliximab exposure, including: active systemic infection, untreated active or latent tuberculosis, history of demyelinating disease, moderate to severe congestive heart failure (NYHA Class III/IV), or history of malignancy within the past 5 years.
  • Use of systemic biologic agents within the past 6 months (12 months for systemic anti-TNF-α therapy).
  • Pregnancy, breastfeeding, or intention to become pregnant during the study.
  • Participation in another clinical trial with an investigational drug within the past 30 days.
  • Ability to understand and sign informed consent and to comply with study procedures and treatment administration.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Mexico · 1 center
  • Instituto de Oftalmología Conde de Valenciana — Mexico City

Identifiers

NCT: NCT07671222 · CEI-2025-11-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗