NCT02129673已完成1 期
A Phase 1/2 Multicenter, Randomized, Controlled Dose-Finding Study to Evaluate the Safety and Ocular Hypotensive Efficacy of 3 Dose Levels of the VS101 Subconjunctival Latanoprost Insert for 3 Months in Subjects With Open-Angle Glaucoma or Ocular Hypertension
ViSci Ltd.1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Intra-ocular pressure
研究概览
简要总结
Slow release formulation of latanoprost is compared for safety and pressure-lowering efficacy with topically administration of commercially available latanoprost in patient with glaucoma and ocular hypertension
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
- Single (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
- •Age > 18
- •Open angle glaucoma or Ocular Hypertension
排除标准
- •uncontrolled medical conditions
- •wearing of contact lenses
研究组 & 干预措施
VS101 Insert Dose A
Experimental
VS101 Insert Dose A placed under the conjunctiva
干预措施: VS101 Insert Dose A (Drug)
VS101 Insert Dose B
Experimental
VS101 Insert Dose B placed under the conjunctiva
干预措施: VS101 Insert Dose B (Drug)
VS101 Insert Dose C
Experimental
VS101 Insert Dose C placed under the conjunctiva
干预措施: VS101 Insert Dose C (Drug)
Latanoprost 0.005% eye drops
Active Comparator
Latanoprost 0.005% eye drops administered once daily on the eye
干预措施: Latanoprost 0.005% eye drops (Drug)
结局指标
主要结局
Intra-ocular pressure
时间窗: 12 weeks
次要结局
- Intra-ocular pressure(4 weeks)
研究者
研究点 (1)
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