A Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Intravenous Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4
研究概览
简要总结
This study assessed the effects of a single intravenous dose of secukinumab (AIN457) 10 mg/kg or canakinumab (ACZ885) 10 mg/kg on the signs and symptoms of dry eye. In addition, the pharmacokinetic, pharmacodynamic, and safety profiles of secukinumab and canakinumab were assessed. Blood samples were collected for the analysis of the effect of secukinumab and canakinumab on select biomarkers.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients age 18-85 with a diagnosis of moderate to severe dry eye.
- •Schirmer test without anesthesia ≥ 1 and < 10 mm wetting over 5 minutes in at least 1 eye.
- •Tear break up time < 7 seconds in at least 1 eye.
- •Corneal staining score ≥ 3 (National Eye Institute [NEI] grading scale).
- •Conjunctival redness of ≥
- •Ocular surface disease index of modest to severe.
- •Ability to provide informed consent.
排除标准
- •Pregnant or breastfeeding women.
- •Hemoglobin < 10 g/dl.
- •Total white blood count (WBC) outside the range of 3000-14,000/µl.
- •Platelets < 100,000/µl.
- •Use of ocular, periocular, or systemic steroids within 60 days prior to screening.
- •Use of contact lenses or prior corneal refractive surgery in either eye.
- •Requirement of eye drop use during the study.
- •Anesthetic or neurotrophic corneas.
- •Temporary punctal plugs.
- •Recent or planned exposure to live vaccinations.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4
时间窗: Baseline to Week 4
Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of each eye. Staining was assessed in 5 zones of the cornea (central plus 4 quadrants) and rated on a scale of 0 (no staining) to 3 (severe, confluent staining). A mean of the 5 zones for the study eye was calculated. A higher score indicates a drier eye. A negative change score indicates improvement in dryness.
次要结局
- Change From Baseline on the Ora Corneal Staining Scale at Weeks 1, 4, and 8(Baseline to Weeks 1, 4, and 8)
- Change From Baseline on the Schirmer Test at Weeks 1, 4, and 8(Baseline to Weeks 1, 4, and 8)
- Change From Baseline in Tear Film Breakup Time at Weeks 1, 4, and 8(Baseline to Weeks 1, 4, and 8)
- Change From Baseline on the Conjunctival Redness Scale (Ora) at Weeks 1, 4, and 8(Baseline to Weeks 1, 4, and 8)
- Change From Baseline in the Ocular Surface Disease Index (OSDI) at Weeks 1, 4, and 8(Baseline to Weeks 1, 4, and 8)
- Desire for Artificial Tear Use at Day 1 and Weeks 1, 4, and 8(Day 1 and Weeks 1, 4, and 8)
- Change From Baseline in Best Corrected Visual Acuity at Weeks 1, 4, and 8(Baseline to Weeks 1, 4, and 8)