NCT00762645已完成4 期
A Twelve-Week, Double Masked, Parallel Group, Primary-Therapy Pilot Study of the Safety and Efficacy of Travoprost 0.004% Compared to Pilocarpine 1% in Patients With Chronic Angle-Closure Glaucoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Mean Intraocular Pressure (IOP)
研究概览
简要总结
The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG).
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
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
- •Age ≥ 18 years
- •Chronic Angle Closure Glaucoma (CACG)
- •21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM
- •Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit
- •Anterior chamber angle in which the trabecular meshwork is not visible for ≥180 degrees in gonioscopy without indentation
- •Peripheral anterior synechiae (PAS)
排除标准
- •Traumatic damage of the anterior chamber angle
- •History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months
- •Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12 days to 14 weeks
- •Visual Acuity ≥ 1.0
- •Contact lenses wearer
研究组 & 干预措施
Travoprost 0.004% (Travatan)
Experimental
One drop in each eye, once daily at 9 AM
干预措施: Travoprost 0.004% (Travatan) (Drug)
Pilocarpine 1%
Active Comparator
One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks
干预措施: Pilocarpine 1% (Drug)
结局指标
主要结局
Mean Intraocular Pressure (IOP)
时间窗: 4PM at Week 12 Visit
次要结局
- Number of Patients With Peripheral Anterior Synechiae (PAS)(Week 12 Visit)
研究者
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