A Phase II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost and Placebo 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
- 91
- 主要终点
- Intraocular pressure (mmHg)
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution.
详细描述
This is a 28-day randomized, observer-masked, placebo-and active-controlled, parallel-group, multi-center, study investigating the safety and efficacy of four concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of DE-117) in subjects with primary open-angle glaucoma or ocular hypertension.
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 (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
- •Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
- •Qualifying intraocular pressure in at least one eye at Baseline
- •Qualifying corrected ETDRS visual acuity in each eye
- •Qualifying central cornea thickness in each eye
排除标准
- •Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
- •Diagnosis of primary open-angle glaucoma or ocular hypertension due to etiology known to be non-responsive to conventional drug therapy
- •Evidence of advanced glaucoma, visual field defect or progressive visual field loss that that do not meet the study criteria
- •History of ocular surgery specifically intended to lower IOP
- •History of any ocular or systemic abnormality or condition that may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in the study
- •Intended or current use of any ocular medications other than study medications during the study
- •Use of contact lenses within one week prior to Baseline (Day 1) until end of treatment
- •Known allergy or sensitivity to any components of the study medications
- •Use of steroids (systemic) within 30 days prior to Visit 1 (Screening)
- •Anticipate the need to initiate or modify an existing chronic therapy that could substantially affect IOP or the study outcomes during the study period
- •Females who are pregnant, nursing or planning a pregnancy
研究组 & 干预措施
latanoprost ophthalmic solution
One drop latanoprost 0.005% in each eye daily for 28 days
干预措施: latanoprost ophthalmic solution (Drug)
Group 1: DE-117 ophthalmic solution
One drop DE-117 Low Dose in each eye daily for 28 days
干预措施: DE-117 ophthalmic solution (Drug)
Group 2: DE-117 ophthalmic solution
One drop DE-117 Low Middle Dose in each eye daily for 28 days
干预措施: DE-117 ophthalmic solution (Drug)
Group 3: DE-117 ophthalmic solution
One drop DE-117 High Middle Dose in each eye daily for 28 days
干预措施: DE-117 ophthalmic solution (Drug)
Group 4: DE-117 ophthalmic solution
One drop DE-117 High Dose in each eye daily for 28 days
干预措施: DE-117 ophthalmic solution (Drug)
placebo (vehicle of DE-117) ophthalmic solution
One drop DE-117 vehicle in each eye once daily for 28 days
干预措施: Placebo (Other)
结局指标
主要结局
Intraocular pressure (mmHg)
时间窗: Day 1, Day 8, Day 15 and Day 29
Intraocular pressure (mmHg) measurements will be collected at each visit using Goldmann applanation tonometry
次要结局
- Adverse events(Day 1, Day 8, Day 15 and Day 29)
- Ocular signs and symptoms(Day 1, Day 8, Day 15 and Day 29)