NCT05495269已完成2 期
Pilot, Open-label Study of Safety and Tolerability of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
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
- 2
- 试验地点
- 1
- 主要终点
- Systemic safety
研究概览
简要总结
Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye.
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
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 12 and 19 years of age at Screening.
- •Diagnosed with SWS
- •Elevated IOP
- •Willing to continue current dosing regimen of IOP-lowering medications
- •Able to provide informed consent and follow study instructions
排除标准
- •Expected to undergo IOP-lowering surgery
- •Incisional or laser surgery of any type 4 months prior to study
- •Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis, history of herpes simplex keratitis in either eye
- •History of or active clinically significant ocular disease
- •Use of topical ocular corticosteroids in the 6 weeks prior to study
- •Patient cannot be applanated or tolerate IOP measurements
- •Patient is pregnant or lactating
- •Uncontrolled systemic disease that can interfere with study participation
- •Inability to self-dose or identify a caregiver for all study eye drop administration
研究组 & 干预措施
QLS-101, 2.0%
Experimental
Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes
干预措施: QLS-101 ophthalmic solution, 2.0 % (Drug)
结局指标
主要结局
Systemic safety
时间窗: Over 28 days
Incidence of systemic TEAEs
Ocular safety
时间窗: Over 28 days
Incidence of ocular treatment emergent adverse events (TEAEs)
次要结局
- Ocular hypotensive effectiveness(28 days)
研究者
研究点 (1)
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