Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution - A Double-Masked, Placebo-Controlled, Phase 3b Clinical Trial (Whistler)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in AHD
研究概览
简要总结
This is a double-masked, placebo-controlled study which will determine the action of NCX 470 ophthalmic solution, 0.1% on aqueous humor dynamic parameters in healthy volunteers or subjects with OHT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •≥18 years of age
- •Either gender
- •Subjects without glaucoma
- •Qualifying IOP at Screening Visit
排除标准
- •Narrow anterior chamber angles or disqualifying central corneal thickness in either eye
- •Clinically significant ocular disease in either eye
- •Uncontrolled systemic disease
- •Serious hypersensitivity to topical anesthetic eye drops
- •Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications
研究组 & 干预措施
NCX 470 0.1%
NCX 470 0.1% - one drop in the randomized eye once a day for 8 days
干预措施: NCX 470 (Drug)
Placebo
Artificial tears - one drop in the randomized eye once a day for 8 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in AHD
时间窗: 8 days
The primary efficacy endpoint is change from baseline in aqueous humor dynamics AHD). AHD is calculated by using well establish techniques which include capturing the following: Aqueous humor flow rates from fluorescein clearance; Outflow facility using constant weigh tonography; Episcleral venous pressure using a venomanometer. The change in ADH will be calculate in normals following 8 (±1) days of dosing of NCX 470 0.1% compared to placebo.
次要结局
未报告次要终点