A Randomized Active-controlled Study to Evaluate Safety and Tolerability of QLS-101 Versus Timolol Preservative Free (PF) Ophthalmic Solution in Subjects With Normal Tension Glaucoma (NTG)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ocular safety
研究概览
简要总结
A randomized active-controlled multi-site double-masked 28 day study to evaluate the safety and tolerability of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with normal tension glaucoma
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
- Double (Participant, Investigator)
盲法说明
Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the investigational product (IP) identity until after the final database is locked. IPs will be provided in identical-appearing pouches to maintain masking.
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
- •All secondary glaucomas
- •Previous glaucoma intraocular or laser surgery (selective laser trabeculoplasty permitted when done 18 months or longer from Screening)
- •Refractive surgery
- •Ocular infection or inflammation
研究组 & 干预措施
QLS-101 ophthalmic solution 1.0%
Ophthalmic solution once daily (QD) dosing in both eyes (OU) for 14 days followed by 14 days of twice daily (BID) dosing.
干预措施: QLS-101 (Drug)
Timolol maleate PF 0.5% ophthalmic solution
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
干预措施: Timolol maleate PF 0.5% ophthalmic solution (Drug)
QLS-101 ophthalmic solution 2.0%
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
干预措施: QLS-101 (Drug)
结局指标
主要结局
Ocular safety
时间窗: 86 days
Number of participants with treatment-related adverse events will be monitored
次要结局
- Ocular hypotensive efficacy(14 days)