Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease

ConditionsSjogren Syndrome Sjogren Syndrome With Keratoconjunctivitis Dry Eye Disease (DED)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

38 Participants

are divided into 2 treatment groups

Group A: Infliximab groupExperimental treatment 1 intervention

Group B: Vehicle groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Ocular Surface Disease Index (OSDI)

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

Time frame

6 weeks.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto de Oftalmología Fundación Conde de Valenciana

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: