A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 417
- 试验地点
- 33
- 主要终点
- Intraocular Pressure (IOP) at Week 1
研究概览
简要总结
This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months.
Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:
- DE-117 Ophthalmic Solution once daily and Vehicle once daily, or
- Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3.
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
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •glaucoma or ocular hypertension
排除标准
- •Females who are pregnant, nursing, or planning a pregnancy
- •Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements
研究组 & 干预措施
DE-117 Ophthalmic Solution
Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months
干预措施: DE-117 Ophthalmic Solution (Drug)
Timolol Maleate Ophthalmic Solution 0.5%
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months
干预措施: Timolol Maleate Ophthalmic Solution 0.5% (Drug)
结局指标
主要结局
Intraocular Pressure (IOP) at Week 1
时间窗: 08:00, 10:00 and 16:00 at Week 1
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day.
Intraocular Pressure (IOP) at Week 6
时间窗: 08:00, 10:00 and 16:00 at Week 6
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day.
Intraocular Pressure (IOP) at Month 3
时间窗: 08:00, 10:00 and 16:00 at Month 3
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day.
次要结局
- Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)(08:00, 10:00 and 16:00 at week 1)
- Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)(08:00, 10:00 and 16:00 at week 6)
- Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)(08:00, 10:00 and 16:00 at month 3)
- Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)(Month 3)
- Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint)(week 1)