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临床试验/NCT05441930
NCT05441930撤回1 期

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

PolyActiva Pty Ltd3 个研究点 分布在 2 个国家开始时间: 2023年6月23日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Levofloxacin Ocular Implant

Experimental

Biphasic levofloxacin antibiotic implant

干预措施: Levofloxacin Ocular Implant (Drug)

Control

Active Comparator

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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