Dry Eye Disease (DED), Sjogren Syndrome, Sjogren Syndrome With Keratoconjunctivitis
Conditions
Keywords
Dry eye disease, Sjogren syndrome, Sjogren disease, Autoimmune dry eye
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.
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
DRUGInfliximab 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.
DRUGLoteprednol
The comparator is an identical vehicle (CMC 1% without infliximab), which helps isolate the effect of infliximab itself.
Sponsors
Instituto de Oftalmología Fundación Conde de Valenciana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Surface Disease Index (OSDI) | 6 weeks. | Measures patient-reported symptoms. Outcome is assesed from baseline to 6 weeks. |
Countries
Mexico
Contacts
CONTACTGustavo Ortiz-Morales, MD
PRINCIPAL_INVESTIGATOREnrique Graue-Hernandez, MD, MSc
Instituto de Oftalmologia Fundacion Conde de Valenciana
Outcome results
None listed