NCT00443924已完成1 期
A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Ascending Dose Study of INS115644 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Safety and tolerability
研究概览
简要总结
The purpose of this trial is to evaluate the safety and tolerability of INS115644 Ophthalmic Solution in subjects with bilateral ocular hypertension or early primary open angle glaucoma and to investigate the intraocular pressure lowering effects of INS115644 Ophthalmic Solution.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma
- •Have best corrected visual acuity in both eyes of at least +0.5 or better
- •Have normal endothelial cell counts and morphology
排除标准
- •Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma
- •Have a history of any type of intraocular surgery, except for cataract surgery
- •Have had cataract surgery within three months
研究组 & 干预措施
1
Placebo Comparator
Arm 1
干预措施: Placebo (Drug)
2
Experimental
Arm 2
干预措施: INS115644 Ophthalmic Solution (Drug)
3
Experimental
Arm 3
干预措施: INS115644 Ophthalmic Solution (Drug)
4
Experimental
Arm 4
干预措施: INS115644 Ophthalmic Solution (Drug)
5
Experimental
Arm 5
干预措施: INS115644 Ophthalmic Solution (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 28 days
Changes in intraocular pressure
时间窗: 28 days
次要结局
未报告次要终点
研究者
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