A Twelve-Week, Double Masked, Parallel Group, Study of Travoprost 0.004% Compared to Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Mean Intraocular Pressure (IOP) at 9 AM
研究概览
简要总结
To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
详细描述
To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
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
- •≥18 years;
- •IOP=16-30mmHg
- •OH or OAG with visual filed abnormality:
- •≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%,
- •Glaucoma Hemifield Test outside normal limits,
- •Corrected Pattern Standard Deviation with p <5%
排除标准
- •Previous damage of anterior chamber angle;
- •ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0;
- •contact lens wearer;
- •severe central field loss;
- •uncontrolled cardiovascular, hepatic or renal disease;
- •any medication within past 1 month.
研究组 & 干预措施
Travoprost 0.004%
Travoprost 0.004%
干预措施: Travoprost 0.004% Ophthalmic Solution (Travatan) (Drug)
Timolol 0.5%
Timolol 0.5%
干预措施: Timolol 0.5% Ophthalmic Solution (Timoptic) (Drug)
结局指标
主要结局
Mean Intraocular Pressure (IOP) at 9 AM
时间窗: At Week 12 - At the 9 AM time point for the patient's worse eye.
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Week 12 - Mean IOP At 4 PM
时间窗: At the 4 PM time point for the patient's worse eye.
Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
次要结局
- Mean IOP Change From Baseline at 9 AM(Baseline to Week 12 - at 9 AM)
- Mean IOP Change at 4 PM(Baseline to Week 12 - at 4 PM)