NCT04061044已完成3 期
A Prospective, Multicenter, Open Label Extension Study to Evaluate the Long Term Safety of OTX-TP
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
研究概览
简要总结
To evaluate the long term safety of repeat dose OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension.
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
- •Had prior bilateral treatment and completion, through a minimum of week 12, of the OTX-16-002 trial
- •Are informed of the nature of the study and subject is able to comply with study requirements and visit schedule for one year
- •Have provided written informed consent, approved by the appropriate Institutional Review Board
排除标准
- •Had more than 1 replacement, per eye, during participation in the OTX-16-002 trial
- •Had punctal or canaliculi related adverse events during the OTX-16-002 trial which required discontinuation (e.g., canaliculitis)
- •Used prohibited medications during the OTX-16-002 study, or the period between OTX-16-002 and this trial (with the exception of short term medication used to treat an adverse event or rescue therapy)
- •Missed more than 2 visits during participation in the OTX-16-002 trial
研究组 & 干预措施
Treatment
Experimental
干预措施: Ophthalmic Insert (Drug)
结局指标
主要结局
Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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