Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto de Oftalmología Fundación Conde de Valenciana
About this 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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Infliximab 0.1%
- Loteprednol
Treatment groups
38 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov