A Pilot, Double-masked, Vehicle-controlled, Randomized Study to Evaluate the Safety and Tolerability of QLS-111 Versus Vehicle in Combination With Latanoprost Treatment in Subjects With Open-angle Glaucoma and/or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of ocular treatment-emergent adverse events (TEAEs)
研究概览
简要总结
Qlaris Phase 2 clinical study investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in combination with latanoprost in open-angle glaucoma (OAG) and/or ocular hypertension (OHT) patients.
详细描述
Pilot, double-masked, vehicle-controlled, randomized, prospective parallel study of 14-day once daily evening (QPM) dosing, followed by 14-day twice daily (BID) dosing of an investigational product (IP), QLS-111, or vehicle as concomitant therapy with monotherapy latanoprost a PGA treatment that is administered QPM. Both eyes (OU) will be dosed. The study is comprised of seven (7) visits and approximately 28 days of IP 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, study staff, Sponsor and designates involved in the conduct, monitoring and outcome evaluation of the study will be masked to IP assignment identity until final database lock is complete. IP will be provided in in identical packaging. Unmasked statistician will prepare the randomization schedule.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 years or older
- •Able and willing provide signed informed consent (assent)
- •mild to moderate OAG or OHT in at least one eye and current or previous treatment with PGA. Exhibits decrease (i.e., >20% from reported pre- treatment) in intraocular pressure (IOP). Patient is willing to continue latanoprost throughout the study.
- •IOP ≥19 mmHg at 08:00 hour (H) at qualification visits prior to randomization
排除标准
- •History of active ocular disease other than mild to moderate OAG/OHT
- •Nonresponse to and/or noncompliant with PGA treatment
- •Use of other topical ocular medications with exception of the PGA which the patient will use throughout the study
- •Moderate to severe glaucomatous damage in either eye
- •Previous glaucoma intraocular surgery in either eye (e.g., trabeculectomy, tubes, cyclodestructive procedures, diode) with exception of selective laser trabeculoplasty (SLT) if done less than 12 months from screening, trabecular meshwork minimally invasive glaucoma surgery (MIGS) when combined with cataract surgery and done less than 12 months from screening.
- •significant ocular trauma, or intraocular surgery (e.g., cataract extraction/intraocular lens insertion) or extensive retinal laser treatment, refractive surgery in either eye.
- •Ocular infection, inflammation (e.g., uveitis), moderate to severe blepharitis/meibomitis and/or severe keratoconjunctivitis sicca in either eye at screening, history of herpes simplex keratitis, in either eye.
- •Clinically significant retinal disease in either eye
- •Clinically significant systemic or psychiatric disease
- •Participation in any investigational study within 30 days prior to screening
- •Pregnant or lactating
研究组 & 干预措施
Experimental: QLS-111 ophthalmic solution
Qlaris' IP, QLS-111 ophthalmic solution, provided in 3 concentrations (0.015%, 0.03%, and 0.075%), preservative free (PF), single-use units, masked.
干预措施: QLS-111, 0.015% (Drug)
Experimental: QLS-111 ophthalmic solution
Qlaris' IP, QLS-111 ophthalmic solution, provided in 3 concentrations (0.015%, 0.03%, and 0.075%), preservative free (PF), single-use units, masked.
干预措施: QLS-111, 0.030% (Drug)
Experimental: QLS-111 ophthalmic solution
Qlaris' IP, QLS-111 ophthalmic solution, provided in 3 concentrations (0.015%, 0.03%, and 0.075%), preservative free (PF), single-use units, masked.
干预措施: QLS-111, 0.075% (Drug)
Placebo comparator: Vehicle ophthalmic solution
Inactive control (0.00%), PF, single-use units, masked.
干预措施: QLS-111 vehicle ophthalmic solution (Drug)
结局指标
主要结局
Incidence of ocular treatment-emergent adverse events (TEAEs)
时间窗: 28 days
Ocular safety and tolerability
Clinically significant change in findings on fundus exam
时间窗: 28 days
Ocular safety and tolerability
Clinically significant change in blood pressure
时间窗: 28 days
Systemic safety and tolerability
Clinically significant change in visual acuity
时间窗: 28 days
Ocular safety and tolerability
Clinically significant change in findings on slit lamp exam
时间窗: 28 days
Ocular safety and tolerability
Incidence of systemic (TEAEs)
时间窗: 28 days
Systemic safety and tolerability
Clinically significant change in heart rate
时间窗: 28 days
Systemic safety and tolerability
次要结局
- Change from baseline (CFB) of mean diurnal IOP in the study eye(28 days)
- CFB in IOP at various timepoints in the study eye(28 days)