NCT04819269已完成3 期
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
Sylentis, S.A.2 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2021年5月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.
研究概览
简要总结
This study will examine the efficacy and safety of tivanisiran sodium eye drops versus vehicle after a 2-week run-in phase when dosed once daily for 3 months in subjects with signs and symptoms of dry eye disease (DED) due to 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
- Double (Participant, Investigator)
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
- •Subject is a male or a female aged ≥ 18 years
- •Have given their written consent to participate in the study
- •Use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection
- •Willing to not use AT or autologous serum for the study duration
- •VAS scale for Dry Eye Symptom Score ≥ 40
- •Total CFS ≥ 5
- •Schirmer's test with anesthesia < 10 mm/5min
- •Patients with Sjögren Syndrome
排除标准
- •Any concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications at the time of entry into the study
- •Use of contact lenses during the study
- •Significant Eye diseases according to investigator's opinion
研究组 & 干预措施
Tivanisiran sodium ophthalmic solution
Active Comparator
干预措施: Tivanisiran sodium ophthalmic solution (Drug)
Vehicle ophthalmic solution
Placebo Comparator
干预措施: Vehicle ophthalmic solution (Drug)
结局指标
主要结局
Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.
时间窗: 85 days
Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening.
时间窗: 85 days
次要结局
未报告次要终点
研究者
研究点 (2)
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