A Prospective, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (Travoprost) Implant in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Ocular Treatment Emergent Adverse Events
研究概览
简要总结
To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.
详细描述
This is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of OTX-TIC intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. The subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the OTX-TIC implant).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Have a documented diagnosis of ocular hypertension or primary open-angle glaucoma
- •Have IOP that is currently controlled as assessed by the Investigator
- •Have open, normal appearing anterior chamber angles as determined by gonioscopy
排除标准
- •Have closed angle glaucoma, narrow angle glaucoma, pseudoexfoliation syndrome, pseudoexfoliation glaucoma, pigment dispersion or pigmentary glaucoma, glaucoma diagnosis prior to 15 years of age, inflammatory, neovascular or other secondary
- •Have a known or suspected allergy and/or hypersensitivity to a prostaglandin (i.e. travoprost), fluorescein or to any component of the study products
研究组 & 干预措施
OTX-TIC-Cohort 1
15 µg (formulation1) implant
干预措施: OTX-TIC (Drug)
OTX-TIC-Cohort 2
26 µg (formulation1) implant
干预措施: OTX-TIC (Drug)
OTX-TIC-Cohort 3
15 µg (formulation 2) implant
干预措施: OTX-TIC (Drug)
OTX-TIC-Cohort 4
5 µg (formulation 3) implant
干预措施: OTX-TIC (Drug)
结局指标
主要结局
Ocular Treatment Emergent Adverse Events
时间窗: Through study completion, 6 months
All adverse events will be captured throughout the study
Efficacy Outcome
时间窗: Diurnal IOP [12 Week Visit]
IOP measurements at 8 am
次要结局
未报告次要终点