NCT01343082已完成3 期
A Long-term Open-label Study of DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension -Phase 3-
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Change From Baseline in IOP (Intraocular Pressure) at End of Study
研究概览
简要总结
Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with open angle glaucoma or ocular hypertension
- •Provided signed, written informed consent
- •20 years of age and older
- •If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study
排除标准
- •Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
- •Presence of any abnormality or significant illness that could be expected to interfere with the study.
研究组 & 干预措施
1
Experimental
DE-111 ophthalmic solution
干预措施: DE-111 ophthalmic solution (Drug)
结局指标
主要结局
Change From Baseline in IOP (Intraocular Pressure) at End of Study
时间窗: Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
次要结局
未报告次要终点
研究者
研究点 (1)
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