A Randomized, Multi-site, Double-masked Study Evaluating the Safety and Tolerability of QLS-111 Vs Vehicle in Primary Open-angle Glaucoma or Ocular Hypertension Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Clinically significant changes in heart rate (HR)
研究概览
简要总结
Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.
详细描述
A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the safety and tolerability of QLS-111 versus vehicle in subjects with primary open-angle glaucoma or ocular hypertension. Primary objective is to evaluate the ocular and systemic safety and tolerability of 3 concentrations of QLS-111 compared to vehicle control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3 concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice daily (BID) dosing versus vehicle with QAM, QPM, and BID dosing.
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)
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 IP identity until after the final database is locked. IP will be provided in identical packaging. Unmasked statistician preparing the masked randomization schedule.
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
- •18 years or older
- •Able to provide written acknowledgement of giving informed consent
- •Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with documented historic IOP value(s) ≥24 mmHg, in either eye
- •Post-washout IOP ≥22 mmHg in morning on Visits 2 and 3 and ≥18 mmHg at noon on Visit 2
排除标准
- •IOP >34 mmHg
- •Severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications
- •Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes, cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done no earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed if done no earlier than 1 year from study)
- •Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
- •Use of other ophthalmic concomitant medications during the study
- •Uncontrolled hypertension or hypotension
- •Significant systemic or psychiatric disease
- •Participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with Qlaris investigational product
- •Pregnant or lactating
研究组 & 干预措施
QLS-111 ophthalmic vehicle solution
Inactive control (0.00%). QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.
干预措施: QLS-111 ophthalmic vehicle solution (Other)
结局指标
主要结局
Clinically significant changes in heart rate (HR)
时间窗: 21 days
Systemic safety and tolerability: vital signs
Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)
时间窗: 21 days
Ocular safety and tolerability: adverse events (AEs)
Clinically significant change in findings on fundus exam
时间窗: 21 days
Ocular safety and tolerability: fundus
Clinically significant change in visual acuity
时间窗: 21 days
Ocular safety and tolerability: visual acuity
Clinically significant change in findings on slit lamp exam
时间窗: 21 days
Ocular safety and tolerability: slit lamp
Incidence of systemic TEAEs
时间窗: 21 days
Systemic safety and tolerability: AEs
Clinically significant changes in blood pressure (BP)
时间窗: 21 days
Systemic safety and tolerability: vital signs
次要结局
- CFB in IOP at various timepoints in the study eye(up to 21 days)
- Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye(21 days)