A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Ascending Dose Study of INS117548 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of INS117548 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 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
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
Arm 1
One drop in each eye every 12 hours for seven days
干预措施: Placebo (Drug)
Arm 2
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
干预措施: INS117548 (Drug)
Arm 3
One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
干预措施: INS117548 (Drug)
Arm 4
One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
干预措施: INS117548 (Drug)
结局指标
主要结局
Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters
时间窗: 15
Rate of discontinuation
时间窗: 15
Incidence of adverse events
时间窗: 15
Compliance
时间窗: 15
次要结局
未报告次要终点