Comparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 158
- 主要终点
- Mean change from baseline in intraocular pressure (IOP)
研究概览
简要总结
The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with 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
- 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
- •Satisfy all informed consent requirements;
- •Diagnosed with open-angle glaucoma or ocular hypertension;
- •Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit;
- •IOP measurements in at least 1 eye as specified in protocol;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;
- •Any form of glaucoma other than open-angle glaucoma;
- •Severe central visual field loss in either eye;
- •Chronic, recurrent or severe inflammatory eye disease;
- •Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;
- •Best-corrected visual acuity (BCVA) worse than 0.60 logarithm of the miniminum angle of resolution (logMAR);
- •Intraocular surgery within the past 6 months;
- •Ocular laser surgery within the past 3 months;
- •Any abnormality preventing reliable applanation tonometry;
- •Severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Travoprost new formulation
Travoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
干预措施: Travoprost ophthalmic solution (new formulation) (Drug)
TRAVATAN
Travoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
干预措施: Travoprost ophthalmic solution, 0.004% (Drug)
Vehicle
Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
干预措施: Vehicle (Drug)
结局指标
主要结局
Mean change from baseline in intraocular pressure (IOP)
时间窗: Baseline, Up to Week 4
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.
次要结局
- Mean intraocular pressure(Baseline, Up to Week 4)
- Mean percent change from baseline in IOP(Baseline, Up to Week 4)