A Phase II, Observer Masked, Active Controlled Study of SYL040012 for the Treatment of Elevated Intraocular Pressure in Patients With Open-angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 21
- 主要终点
- Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
研究概览
简要总结
The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.
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)
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
- •Patients older than 18 years of either sex
- •Good or fair general health as assessed by the investigator.
- •Signed informed consent prior to any clinical trial-related procedures
- •Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
- •Post-washout mean IOP above target range
- •BCVA 1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200)
- •Stable visual field
- •Central corneal thickness 480-620 μm
- •Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes
排除标准
- •Pregnant or breastfeeding females
- •Females of childbearing potential not willing to use a medically acceptable contraceptive method
- •Clinically significant systemic disease
- •Changes of systemic medication that could have a substantial effect on IOP
- •Known hypersensitivity to any component of the formulations
- •Unable to comply with the clinical trial requirements
- •Clinically significant abnormalities in laboratory tests
- •Severe visual field defect
- •Any secondary glaucoma
- •Pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles.
- •IOP ≥ 35 mm Hg in any eye
- •Previous non-laser glaucoma surgery or glaucoma laser procedures (e.g., laser trabeculoplasty) and refractive surgery
- •Any ocular surgery or laser treatment, cataract extraction or ocular trauma within 6 months prior to Baseline
- •Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 0), or a history of herpes simplex keratitis
- •Clinically significant ocular disease
研究组 & 干预措施
SYL040012 (bamosiran) 0.375% eye drops
1 drop in each eye once daily for 28 consecutive days
干预措施: 1 drop of 0.375% SYL040012 (bamosiran) (Drug)
SYL040012 (bamosiran) 0.750% eye drops
1 drop in each eye once daily for 28 consecutive days
干预措施: 1 drop of 0.750% SYL040012 (bamosiran) (Drug)
SYL040012 (bamosiran) 1.125% eye drops
1 drop in each eye once daily for 28 consecutive days
干预措施: 1 drop of 1.125% SYL040012 (bamosiran) (Drug)
SYL040012 (bamosiran) 1.5% eye drops
1 drop in each eye once daily for 28 consecutive days
干预措施: 1 drop of 1.5% SYL040012 (bamosiran) (Drug)
Timolol maleate 0.5% ophthalmic solution
1 drop in each eye twice daily for 28 consecutive days
干预措施: 1 drop of 0.5 % timolol maleate (Drug)
结局指标
主要结局
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
时间窗: Baseline and Day 28
次要结局
- Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm(Baseline and Day 14)
- Change From Baseline in the Glaucoma Quality of Life Questionnaire (GQL-15) Scores Within Each Treatment Arm(Baseline and Day 29)