A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety Following Topical Administration of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
This is a single-center, open-label, randomized study to assess the plasma pharmacokinetic profile of LNZ101 and LNZ100.
详细描述
To characterize the plasma pharmacokinetics and safety profile of LNZ101 and LNZ100 ophthalmic solutions in both eyes once a day for 8 days in healthy volunteers with presbyopia
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
- None
盲法说明
this is an open label study.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each subject must:
- •Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
- •Be able and willing to follow all instructions and attend all study visits;
- •Be 45-75 years of age of either sex and any race or ethnicity;
- •Be presbyopic in both eyes;
排除标准
- •Each subject must not:
- •Have known contraindications or sensitivity to the use of the investigational drug or its components, or any other medications required by the protocol;
- •Have any active systemic or ocular disorder other than refractive disorder;
- •Have prior, current or anticipated use of any contact lenses during study participation;
- •Have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that could affect ophthalmic drop absorption;
- •Have anticipated inability to stay confined on required study days;
研究组 & 干预措施
LNZ101
Aceclidine 1.75% / Brimonidine combination (non-preserved) ophthalmic solution
干预措施: Aceclidine + Brimonidine (Drug)
LNZ100
Aceclidine 1.75% (non-preserved) ophthalmic solution
干预措施: Aceclidine (Drug)
结局指标
主要结局
AUC0-t
时间窗: Day 1 and Day 8
Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100
T1/2
时间窗: Day 1 and Day 8
Terminal half-life of LNZ100 and LNZ101
Cmax
时间窗: Day 1 and Day 8
Maximum plasma concentrations of LNZ100 and LNZ101
Tmax
时间窗: Day 1 and Day 8
Time of maximum plasma concentrations of LNZ100 and LNZ101
AUC0-inf
时间窗: Day 1 and Day 8
Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101
次要结局
未报告次要终点