A Randomized, Active-controlled, Multi-site, Double-masked, Pilot Study to Evaluate the Safety and Tolerability of QLS-111 Versus Timolol Maleate Preservative Free 0.5% 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
- 37
- 试验地点
- 2
- 主要终点
- Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)
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 normal tension glaucoma patients.
详细描述
A randomized, active-controlled, multi-site, double-masked, pilot study to evaluate the safety and tolerability of QLS-111 0.015% versus Timolol maleate ophthalmic preservative free (PF) 0.5% ophthalmic solution in subjects with NTG. Primary objective is to evaluate the ocular and systemic safety and tolerability of QLS-111 0.015% compared to active control (Timolol).
Secondary objective is to evaluate the ocular hypotensive efficacy of QLS-111 0.015% with once daily evening (QPM) and twice daily (BID) dosing versus Timolol with QPM 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 appearing packaging. Unmasked statistician preparing the masked randomization schedule.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 years or older
- •Able to provide written acknowledgement of giving informed consent
- •Best corrected visual acuity (BCVA) 20/200 or better
- •NTG in both eyes with untreated IOP <21 mmHg at Visit 2 and morning assessment of Visit 3; IOP at morning assessment on Visits 2 and 3 doesn't differ more than 2 mmHg; has open iridocorneal angles, historic IOP <22 mmHg in either eye
排除标准
- •History of angle closure glaucoma, narrow or occludable angle on gonioscope
- •All secondary glaucomas
- •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 1.5 years from study)
- •Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
- •Use of other ophthalmic concomitant medications during the study
- •Refractive surgery
- •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 solution
Qlaris' investigational product, QLS-111 ophthalmic solution, 0.15%, provided in single use vials, masked, and PF.
干预措施: QLS-111 ophthalmic solution (0.015%) (Drug)
Timolol maleate PF 0.5% Ophthalmic Solution
Timolol BID: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) provided in single use vials, masked.
干预措施: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) (Drug)
结局指标
主要结局
Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)
时间窗: 14 days
Ocular safety and tolerability: (AEs)
Clinically significant change in visual acuity
时间窗: 14 days
Ocular safety and tolerability: visual acuity
Clinically significant change in findings on slit lamp exam
时间窗: 14 days
Ocular safety and tolerability: dilated biomicroscopy of eye to observe clinically significant changes from baseline
Clinically significant change in findings on fundus exam
时间窗: 14 days
Ocular safety and tolerability: dilated ophthalmoscopy to observe clinically significant changes from baseline in posterior segment of eye
Incidence of systemic TEAEs
时间窗: 14 days
Systemic safety and tolerability: AEs
Clinically significant changes in blood pressure (BP)
时间窗: 14 days
Systemic safety and tolerability: vital sign, measuring systolic and diastolic blood pressure
Clinically significant changes in heart rate (HR)
时间窗: 14 days
Systemic safety and tolerability: vital signs
次要结局
- Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye(14 days)
- CFB in IOP at various timepoints in the study eye(14 days)