Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease (NCT07671222) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease
Mexico38 participantsStarted 2026-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, act…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Ocular Surface Disease Index (OSDI)
Timeframe: 6 weeks.
Trial details
NCT IDNCT07671222
SponsorInstituto de Oftalmología Fundación Conde de Valenciana