NCT04682288已完成1 期
An Interventional, Open Label, Non-randomized, Phase Ia Safety and Tolerability Study of Levofloxacin Ocular Implant in Subjects Undergoing Routine Cataract Surgery.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Endothelial Cell Density
研究概览
简要总结
This is a multi center, open label, interventional study in one eye of 5 subjects scheduled for uncomplicated cataract surgery with administration of a single Levofloxacin Ocular Implant in the posterior sulcus of the surgical eye at the end of cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of cataract in the intent to treat eye
- •Endothelial cell density in the study eye of at least 2000 cells per mm2
排除标准
- •history of ocular inflammation including, macular degeneration, uveitis, macular edema or corneal edema
- •recent surgery in the study eye
- •subjects receiving a glaucoma device in conjunction with cataract surgery
- •subjects with a compromised posterior capsule during surgery
- •corneal disease that prevents effective imaging of endothelium including Fuch's Dystrophy.
- •sensitivity to fluoroquinolones
研究组 & 干预措施
Levofloxacin Ocular Implant
Experimental
Biphasic levofloxacin antibiotic implant
干预措施: Levofloxacin Ocular Implant (Drug)
结局指标
主要结局
Endothelial Cell Density
时间窗: 90 days
Change in number of central corneal endothelial cells per mm2
Intraocular Pressure (IOP)
时间窗: 90 days
Change in IOP measured by Goldmann applenation tonometry
Ocular Inflammation
时间窗: 90 days
Change assessed according to Standardization of Uveitis Nomenclature (SUN) Grading Scale
次要结局
- Administration procedure(1 week)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)Relapsing Multiple Sclerosis (RMS)NCT02921035Merck KGaA, Darmstadt, Germany594
Unknown
4 期
The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic AgitationSchizophreniaNCT02935998Yang Fude1,000
已完成
2 期
Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to RaltegravirHIV InfectionsNCT02097108Arbeitsgemeinschaft medikamentoese Tumortherapie11
已完成
3 期
Olaparib Tablets Maintenance Monotherapy Ovarian Cancer Patients After Complete or Partial Response to Platinum ChemotherapyRelapsed Ovarian CancerFollowing Complete or Partial Response to Platinum Based ChemotherapyPlatinum SensitiveNCT03534453AstraZeneca229
招募中
不适用
A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer DetectionWomen's Health: Neoplasm of BreastNCT06291896Umbria Bioengineering Technologies10,000