NCT03697811已完成3 期
An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 107
- 试验地点
- 32
- 主要终点
- Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.
研究概览
简要总结
Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.
- •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 after latanoprost Run-in Period.
- •Qualifying Anterior chamber angle.
- •Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.
排除标准
- •Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout.
- •Patients with prior exposure to DE-
- •History of ocular surgery specifically intended to lower IOP
- •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 180 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
DE-117 Ophthalmic Solution 0.002%
Experimental
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
干预措施: DE-117 Ophthalmic Solution (Drug)
结局指标
主要结局
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.
时间窗: Month 3
IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.
次要结局
- Change From Baseline in IOP at Timepoints at Week 2(08:00, 12:00 and 16:00 at Week 2)
- Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6(week 2 and 6)
- Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3(08:00, 12:00 and 16:00 at month 3.)
- Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3(week 2, 6 and month 3)
- Change From Baseline in IOP at Timepoints at Week 6(08:00, 12:00 and 16:00 at Week 6)
- Change From Baseline in IOP at Timepoints at Month 3(08:00, 12:00 and 16:00 at month 3)
- Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2(08:00, 12:00 and 16:00 at week 2)
- Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6(08:00, 12:00 and 16:00 at week 6)
研究者
研究点 (32)
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