试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 主要终点
- 24-hour Area Under the Curve (AUC) in IOP Reduction
研究概览
简要总结
The purpose of this study is to compare the incremental dosing of travoprost ophthalmic solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
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
- •Patients with open-angle glaucoma or ocular hypertension who meet the following IOP criteria:
- •Mean IOP ≥ 24 mmHg in at least 1 eye, with the same eye qualifying at 8 AM at both Day 0 and Day 1;
- •Mean IOP ≤ 36 mmHg in both eyes at all time points on Day 0 and Day
- •Must sign an informed consent form.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Females of childbearing potential who are pregnant, test positive on urine pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast-feeding, or are not using highly effective birth control measures.
- •Current or history of ocular inflammation or infection in either eye within the past 3 months.
- •Corneal thickness greater than 620 µm as determined by pachymetry in either eye.
- •Severe visual field loss.
- •Cup to disc ratio greater than 0.8 in either eye.
- •Intraocular surgery within the past 6 months in either eye.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Trav 0.00013%
Travoprost Ophthalmic Solution, 0.00013%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
干预措施: Travoprost Ophthalmic Solution, 0.00013% (Drug)
Trav 0.00033%
Travoprost Ophthalmic Solution, 0.00033%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
干预措施: Travoprost Ophthalmic Solution, 0.00033% (Drug)
Trav 0.001%
Travoprost Ophthalmic Solution, 0.001%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
干预措施: Travoprost Ophthalmic Solution, 0.001% (Drug)
Trav 0.00267%
Travoprost Ophthalmic Solution, 0.00267%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
干预措施: Travoprost Ophthalmic Solution, 0.00267% (Drug)
TRAVATAN
Travoprost Ophthalmic Solution, 0.004%, 1 drop administered in each eye at 8 pm for 5 days, with 1 drop of vehicle administered at all other timepoints (2-hour intervals)
干预措施: Travoprost Ophthalmic Solution, 0.004% (Drug)
Vehicle
Travoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
干预措施: Travoprost Vehicle (Drug)
结局指标
主要结局
24-hour Area Under the Curve (AUC) in IOP Reduction
时间窗: Day 5
次要结局
未报告次要终点