A Phase IIb, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 323
- 试验地点
- 41
- 主要终点
- Intraocular Pressure at Week 2
研究概览
简要总结
Reduction 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 DE-126, ophthalmic solution in subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).
The IOP will be measured at 3 different times throughout the day, over 4 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, and vital signs. 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
- Double (Participant, Investigator)
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
- •Have been diagnosed of POAG or OHT in both eyes, or one eye with OAG and other with OHT
- •Completed the required wait/washout period
- •Qualifying Day 1 IOP measurement at 3 time-points in both eyes
排除标准
- •Females who are pregnant, nursing, or planning a pregnancy
- •Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period.
- •History of ocular surgery specifically intended to lower IOP in either eye. Laser iridotomy in history is allowed
- •Presence of advanced glaucoma in either eye
研究组 & 干预措施
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD
DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
干预措施: DE-126 Ophthalmic Solution 0.002% QD (Drug)
Timolol Maleate Opthalmic Solution 0.5% BID
Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)
干预措施: Timolol Maleate Ophthalmic Solution 0.5% BID (Drug)
结局指标
主要结局
Intraocular Pressure at Week 2
时间窗: 08:00, 10:00 and 16:00 at Week 2
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Intraocular Pressure at Week 6
时间窗: 08:00, 10:00 and 16:00 at Week 6
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Intraocular Pressure at Month 3
时间窗: 08:00, 10:00 and 16:00 at Month 3
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
次要结局
- Mean Diurnal Intraocular Pressure at Month 3(Three months)