A Multicenter, Double-Masked Study of the Safety and Efficacy of Travoprost Ophthalmic Solution, 0.003% Compared to TRAVATAN in Patients With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,099
- 主要终点
- Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)
研究概览
简要总结
The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypertension.
详细描述
This study consisted of six visits conducted during two sequential phases. The Screening/Eligibility phase included one screening visit and two eligibility visits. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1) at the second eligibility visit. The Treatment phase consisted of three on-therapy visits (Week 2, Week 6, and Month 3).
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
- Triple (Participant, 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
- •Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.
- •Qualifying intraocular pressure at both eligibility visits.
- •Understand and sign an informed consent form.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.
- •Severe central visual field loss in either eye.
- •Chronic, recurrent or severe inflammatory eye disease.
- •Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).
- •Any abnormality preventing reliable applanation tonometry.
- •Hypersensitivity to prostaglandin analogs or to any component of the study medications.
- •Therapy with another investigational agent within 30 days prior to the Screening Visit.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Travoprost 0.003%
Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
干预措施: Travoprost ophthalmic solution, 0.003% (Drug)
TRAVATAN
Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
干预措施: Travoprost ophthalmic solution, 0.004% (Drug)
结局指标
主要结局
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)
时间窗: Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)
As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
次要结局
未报告次要终点