Safety and Efficacy of Topical Infliximab Versus Topical Steroid in Autoimmune Dry Eye Disease: Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in Ocular Surface Disease Index (OSDI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Signs: Ocular Staining Score (OSS, SICCA) ≥
- •Ability to understand and sign informed consent and to comply with study procedures and treatment administration.
排除标准
- •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.
结局指标
主要结局
Change in Ocular Surface Disease Index (OSDI)
时间窗: 6 weeks.
Measures patient-reported symptoms. Outcome is assesed from baseline to 6 weeks.
次要结局
未报告次要终点
研究者
Nicolas Kahuam Lopez
Consultant Cornea and Refractive Surgery Department
Instituto de Oftalmología Fundación Conde de Valenciana