A Phase IIb, Randomized, Observer-Masked, Placebo- and Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-126 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 241
- 试验地点
- 17
- 主要终点
- Intraocular Pressure in the Study Eye at Month 3
研究概览
简要总结
Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss.
This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension.
The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.
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
- Single (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
- •Provide signed written informed consent
- •Diagnosis of POAG or OHT in both eyes
- •Qualifying corrected visual acuity in each eye
- •Qualifying central corneal thickness in each eye
- •Qualifying Day 1 IOP measurement at 3 time-points in both eyes
- •Qualifying Anterior chamber angle
排除标准
- •History of ocular surgery specifically intended to lower IOP
- •Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
- •Advanced glaucoma in either eye
- •Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry
- •Any ocular surgery or ocular laser treatment within 90 days prior to Visit 1 (Screening) and throughout the study in either eye
- •Females who are pregnant, nursing, or planning a pregnancy
研究组 & 干预措施
Ultra-low dose 0.0005% DE-126
干预措施: Topical ultra-low dose of DE-126 Ophthalmic Solution (Drug)
Placebo (Vehicle of DE-126) followed by high dose of DE-126
干预措施: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution (Drug)
Low dose 0.001% DE-126
干预措施: Topical low dose of DE-126 Ophthalmic Solution (Drug)
Medium dose 0.002% DE-126
干预措施: Topical medium dose of DE-126 Ophthalmic Solution (Drug)
High dose 0.003% DE-126
干预措施: Topical high dose of DE-126 Ophthalmic Solution (Drug)
0.005% Latanoprost
干预措施: 0.005% Latanoprost Ophthalmic Solution (Drug)
结局指标
主要结局
Intraocular Pressure in the Study Eye at Month 3
时间窗: 9:00, 13:00 and 17:00 at Month 3
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
次要结局
- Intraocular Pressure in the Study Eye at Week 6(9:00, 13:00 and 17:00 at Week 6)
- Intraocular Pressure in the Study Eye at Week 1 and Week 2(9:00, 13:00 and 17:00 at Week 1 and Week 2)
- Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit(Week 1, Week 2, Week 6 and Month 3.)
- Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit(Week 1, Week 2, Week 6 and Month 3.)
- Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit(Week 1, Week 2, Week 6 and Month 3.)
- Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit(9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.)
- Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit(9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.)
- Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit(WeeK 1, Week 2, Week 6 and Month 3.)
- Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit(Week 1, Week 2, Week 6 and Month 3.)