NCT07671222Not yet recruitingPhase 2
Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease
Safety and Efficacy of Topical Infliximab Versus Topical Steroid in Autoimmune Dry Eye Disease: Randomized Controlled Trial.
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 22 Jun 2026
- Start date
- Dec 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Diseases
- Sjögren's disease
- NCT number
- NCT07671222
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 38
- From Dec 2026 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ocular or eyelid surgery within the past 6 months.
- Use of systemic biologic agents within the past 6 months (12 months for systemic anti-TNF-α therapy).
- Participation in another clinical trial with an investigational drug within the past 30 days.
Other illness
- Active ocular infection (bacterial, viral, fungal) or recent history of herpetic keratitis.
- 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.
Lab values
- Current use of topical corticosteroids or topical immunomodulators (cyclosporine, lifitegrast, tacrolimus, autologous serum) within 30 days prior to enrollment.
Other
- Current or recent use (\< 3 months) of punctal plugs.
- Use of contact lenses during the study period.
- Pregnancy, breastfeeding, or intention to become pregnant during the study.
- Ability to understand and sign informed consent and to comply with study procedures and treatment administration.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto de Oftalmología Conde de Valenciana Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.