Masked, Randomized, Single-site, Crossover Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 Dosed for 14 Days in Adult Subjects With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Ocular adverse events (AEs)
研究概览
简要总结
Safety and tolerability study of 2 concentrations of QLS-101 for adult subjects with Sturge Weber Syndrome (SWS)-related glaucoma due to elevated episcleral venous pressure (EVP).
详细描述
Masked, randomized, single site, crossover study to compare 2 concentrations of QLS-101. Subjects will be randomized to one of 2 concentrations of QLS-101 for the first 14 days of daily dosing, and after a 14-day washout period they will be crossed over to the other concentration for another 14 days of daily dosing. Dose assignment is masked to patient and investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Masked investigational product labeling.
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
- •Diagnosed with SWS.
- •Elevated intraocular pressure (IOP)
- •Willing to continue current dosing regimen of IOP-lowering medications
- •Willing to refrain from contact lens use in the study eye.
排除标准
- •IOP with variability of > 4 mm Hg
- •Expected to undergo IOP-lowering surgery
- •Incisional or laser surgery of any type
- •Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis
- •A 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 Visit 1
研究组 & 干预措施
1% QLS-101
dosed once a day for 14 days as either first or second dosing period per randomization
干预措施: QLS-101ophthalmic solution 1% (Drug)
2% QLS-101
dosed once a day for 14 as either first or second dosing period per randomization
干预措施: QLS-101ophthalmic solution 2% (Drug)
结局指标
主要结局
Ocular adverse events (AEs)
时间窗: 56 days, including a 14-day washout
Standard safety endpoint, ocular AEs, (including elevated IOP)
Visual acuity
时间窗: 56 days, including a 14-day washout
Standard safety endpoint, best corrected visual acuity, Snellen score, change from baseline
Enhance depth imaging optical coherence tomography (EDI-OCT)
时间窗: 56 days, including a 14-day washout
Standard safety endpoint, EDI-OCT, corneal thickness
Slit lamp exam
时间窗: 56 days, including a 14-day washout
Standard safety endpoint, slit lamp exam, abnormalities, changes from baseline
Dilated fundus exam
时间窗: 56 days, including a 14-day washout
Fundus exam, abnormalities, changes from baseline
次要结局
- Ocular hypotensive efficacy(14 days after each dosing timepoint is completed)