Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease (INFLIXIDRY)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sjogren Syndrome; Dry Eye Disease (DED); Sjogren Syndrome With Keratoconjunctivitis
• Intervention / Treatment: Drug: Infliximab 0.1%; Drug: Loteprednol

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.

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gustavo Ortiz-Morales, MD; Phone Number: 5554421700; Email: dr.gortizmor@gmail.com

Study Locations

• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06800
      • Instituto de Oftalmología Conde de Valenciana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infliximab group; 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%; 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.; Other Names: Infliximab
Active Comparator: Vehicle group; 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; The comparator is an identical vehicle (CMC 1% without infliximab), which helps isolate the effect of infliximab itself.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ocular Surface Disease Index (OSDI)	Measures patient-reported symptoms. Outcome is assesed from baseline to 6 weeks.	6 weeks.

Collaborators and Investigators

• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
• Investigators: Principal Investigator: Enrique Graue-Hernandez, MD, MSc, Instituto de Oftalmologia Fundacion Conde de Valenciana

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Dry eye disease; Sjogren syndrome; Sjogren disease; Autoimmune dry eye
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome; Dry Eye Syndromes; Amino Acids, Peptides, and Proteins; Proteins; Polycyclic Compounds; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Steroids; Fused-Ring Compounds; Androstadienes; Androstenes; Androstanes; Loteprednol Etabonate; Infliximab
• Other Study ID Numbers: CEI-2025-11-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No