A Phase II Study to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-Daily DNB-001 in Previously Untreated Patients With Elevated Intraocular Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The reduction of IOP as calculated on the basis of the arithmetic mean of up to six measurements of IOP, comparing baseline to visit 6
研究概览
简要总结
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase 1I Study to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-Daily DNB-001 in Previously Untreated Patients with intraocular Hypertension
详细描述
To evaluate the efficacy of four dosages of mg DNB-001 administered twice daily (bid) per os (p.o.) as an anti-ocular hypertensive agent, compared with placebo administered bid po, for 28 days, in patients with 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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Male or female, at least 18 years old, in general good health, not presently treated for elevated intraocular pressure (IOP), with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score equivalent to a Snellen score of 20/50 or better in each eye and lOP of 21 to 29 mm Hg at baseline.
排除标准
- •Use of intraocular pressure lowering medication within the past 3 months or any history of ocular surgery for glaucoma
- •Evidence of potential angle closure by gonioscopy
- •Abnormal optic disc or visual field consistent with glaucoma
- •Use of topical ocular medications during the study and any evidence of systemic disease that might interfere with the conduct of the study.
研究组 & 干预措施
1
dosage X mg BID
干预措施: DNB-001 (Drug)
2
dosage Y mg BID
干预措施: DNB-001 (Drug)
3
dosage Z mg BID
干预措施: DNB-001 (Drug)
4
dosage 2Z mg BID
干预措施: DNB-001 (Drug)
5
Placebo BID
干预措施: DNB-001 (Drug)
结局指标
主要结局
The reduction of IOP as calculated on the basis of the arithmetic mean of up to six measurements of IOP, comparing baseline to visit 6
时间窗: 28 days of therapy
次要结局
- Percentage change and responder rates - e.g., > 20% reduction in lOP values from baseline to Day 21, Day 14 and Day 7(7, 14, 21 days of therapy)