An Interventional, Open Label, Controlled, Randomized, Pairwise, Phase Ib Safety, Tolerability and Pharmacokinetic (PK) Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Safety of the Levofloxacin Ocular Implant
研究概览
简要总结
Open label controlled interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days.
详细描述
This is a multicenter, open label, controlled, pairwise, interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days. Eligible individuals provide informed consent; and are screened for inclusion in the study.
Once eligible, subject eyes will be randomized to determine which eye will receive the first surgery. After the first surgery, study participants will receive the control treatment consisting of commercially available topical medications. For the second cataract surgery, study participants will receive a single Levofloxacin Ocular Implant in the posterior sulcus in the surgical eye at the end of cataract surgery. No sham dosing will be conducted in the eyes in the control arm.
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
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Levofloxacin Ocular Implant
Biphasic levofloxacin antibiotic implant
干预措施: Levofloxacin Ocular Implant (Drug)
Control
Commercially available topical medications as per LEVO-CS102 Surgical Therapy Procedure.
干预措施: Control (Drug)
结局指标
主要结局
Safety of the Levofloxacin Ocular Implant
时间窗: Day 90
Descriptive summary statistics will be used to assess the number and frequency of ocular and non ocular adverse events
Levofloxacin concentration in aqueous humor at Day 5 in treated eyes
时间窗: Day 5
To determine levofloxacin concentration in aqueous humor at Day 5 in eyes with the Levofloxacin Ocular Implant to facilitate dose adjustment for Phase II studies.
次要结局
- Number of actuations required to administer the implant(Day 0)
