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Набор скоро начнётся NCT07671222

Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease

Фаза II С лечением Sjogren Syndrome Sjogren Syndrome With Keratoconjunctivitis Dry Eye Disease (DED)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Infliximab 0.1%, Loteprednol.
Кому может быть актуально
Состояния в реестре: Sjogren Syndrome, Sjogren Syndrome With Keratoconjunctivitis, Dry Eye Disease (DED). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Мексика
Следующий шаг
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Официальное название

Safety and Efficacy of Topical Infliximab Versus Topical Steroid in Autoimmune Dry Eye Disease: Randomized Controlled Trial.

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Change in Ocular Surface Disease Index (OSDI) [Срок оценки: 6 weeks.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Мексика · 1 центр
  • Instituto de Oftalmología Conde de Valenciana — Mexico City

Идентификаторы

NCT: NCT07671222 · CEI-2025-11-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗