NCT04830397
已完成
2 期
A Randomized Active-controlled Multi-site Double-masked Study to Evaluate the Safety and Tolerability of 3 Concentrations of QLS-101 Versus Timolol Maleate Preservative Free (PF) 0.5% Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
概览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Ocular safety
概览
简要总结
Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension.
详细描述
Multi-site study to evaluate the safety and tolerability of 3 concentrations of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Visual acuity +1.0 logMAR or better
- •Willing to give informed consent
- •Ability to washout from current intraocular pressure lowering medications -
排除标准
- •Severe glaucomatous damage
- •Previous glaucoma intraocular or laser surgery
- •Refractive surgery
- •Ocular infection or inflammation
研究组 & 干预措施
QLS-101 0.5%
Experimental
干预措施: QLS-101 (Drug)
QLS-101 1%
Experimental
干预措施: QLS-101 (Drug)
QLS-101 2%
Experimental
干预措施: QLS-101 (Drug)
Timolol Maleate 0.5% preservative free ophthalmic solution
Active Comparator
干预措施: Timolol Maleate (Drug)
结局指标
主要结局
Ocular safety
时间窗: 100 days
Number of participants with treatment-related adverse events will be monitored
次要结局
- Ocular hypotensive efficacy(28 days)
研究者
研究点 (1)
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