NCT04747808已完成2 期
A Phase 2a Study of Safety, Tolerability, and Efficacy of Drug-Delivering Contact Lens LL-BMT1 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Adverse Event Rate
研究概览
简要总结
This is an open-label, Phase 2a clinical study of LL-BMT1 in patients with primary open-angle glaucoma and ocular hypertension. Study subjects will be treated for 7 days with a single dose of LL-BMT1.
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
- •Male or female, at least 18 years of age at the Screening Visit
- •Diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes
- •At least one eye (called the study eye) must have an untreated intraocular pressure between 22 mmHg and 34 mmHg (inclusive) as measured at 9 am during the Baseline Visit.
- •Best corrected visual acuity of Early Treatment Diabetic Retinopathy Study of 50 letters or better
排除标准
- •Glaucoma or optic neuropathy due to anything other than above noted reasons Cup-to-disc ratio of >0.8 in either eye
- •Corneal thickness <480 or >620 μm
研究组 & 干预措施
LL-BMT1
Experimental
Group 4 extended-wear contact lens printed with bimatoprost
干预措施: LL-BMT1 (Drug)
结局指标
主要结局
Adverse Event Rate
时间窗: Day 7
Number of subjects with adverse events
次要结局
- IOP Changes(Days 1)
- Intraocular Pressure Elevation(Day 7)
研究者
研究点 (1)
Loading locations...
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