Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Travoprost Ophthalmic Topical Cream in Subjects With Open-angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- change from baseline in mean diurnal IOP in the study eye
研究概览
简要总结
The goal of this clinical trial is to learn about the safety of Travoprost Ophthalmic Topical Cream and how well it works in lowering high intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
A low dose, medium dose and high dose of Travoprost Ophthalmic Topical Cream will be compared to timolol maleate ophthalmic solution, 0.5% and to travoprost ophthalmic solution, 0.004%.
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, 18 years of age or older at the Screening Visit;
- •Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form;
- •Diagnosis of OAG (including pigmentary and pseudoexfoliative) or OHT in both eyes;
- •Qualifying IOP in the study eye;
- •Best-corrected visual acuity of approximately 20/80 Snellen in each eye
排除标准
- •Sensitivity or allergy to travoprost or timolol;
- •Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease;
- •History of or current sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock;
- •History of cerebrovascular insufficiency;
- •Any form of glaucoma other than open-angle glaucoma
- •Advanced visual field loss or cup-to-disc ratio of 0.8 or greater
- •Non-qualifying prior surgeries or procedures in either eye
研究组 & 干预措施
Travoprost Ophthalmic Topical Cream low-dose
Travoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days
干预措施: Travoprost Ophthalmic Topical Cream low-dose (Drug)
Travoprost Ophthalmic Topical Cream mid-dose
Travoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days
干预措施: Travoprost Ophthalmic Topical Cream mid-dose (Drug)
Travoprost Ophthalmic Topical Cream high-dose
Travoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days
干预措施: Travoprost Ophthalmic Topical Cream high-dose (Drug)
Timolol maleate ophthalmic solution, 0.5%
Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days
干预措施: Timolol maleate ophthalmic solution, 0.5% (Drug)
Travoprost ophthalmic solution, 0.004%
Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days
干预措施: Travoprost Ophthalmic Solution, 0.004% (Drug)
结局指标
主要结局
change from baseline in mean diurnal IOP in the study eye
时间窗: Day 29
Day 29 mean diurnal IOP minus Baseline mean diurnal IOP in the study eye
次要结局
未报告次要终点