Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease

NCT07671222 | Not Yet Recruiting Phase 2

• 1 other identifier: CEI-2025-11-02
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Dry eye disease; Sjogren syndrome; Sjogren disease; Autoimmune dry eye

Outcome Measures

Primary Outcomes (1)

• Change in Ocular Surface Disease Index (OSDI)

  Measures patient-reported symptoms. Outcome is assesed from baseline to 6 weeks.

  6 weeks.

Study Arms (2)

Infliximab group

EXPERIMENTAL

Arm A: Infliximab Group (Intervention) Participants assigned to this group will receive: Topical infliximab 1 mg/mL (0.1%) in CMC 1%, one drop in each eye four times daily (QID) Topical corticosteroid (loteprednol 0.5%), one drop in each eye QID (standard therapy) This group evaluates whether adding infliximab to standard therapy improves symptoms and ocular surface inflammation.

Drug: Infliximab 0.1%

Vehicle group

ACTIVE COMPARATOR

Participants assigned to this group will receive: Vehicle (CMC 1%) eye drops without infliximab, one drop in each eye four times daily (QID) Topical corticosteroid (loteprednol 0.5%), one drop in each eye QID (standard therapy) Preservative-free artificial tears as needed (rescue treatment) This group serves as the control, allowing comparison against standard treatment plus vehicle.

Drug: Loteprednol

Interventions

Infliximab 0.1% DRUG

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.

Also known as: Infliximab

Infliximab group

Loteprednol DRUG

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

Vehicle group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de Oftalmología Conde de Valenciana

Mexico City, Mexico City, 06800, Mexico

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Dry Eye Syndromes

Interventions

Infliximab; Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Enrique Graue-Hernandez, MD, MSc

  Instituto de Oftalmologia Fundacion Conde de Valenciana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gustavo Ortiz-Morales, MD

CONTACT

5554421700; dr.gortizmor@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cornea and Refractive Surgery Department

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)