NCT01995136已完成4 期
Investigation of the Effect of Travoprost Ophthalmic Solution of Lowering Intraocular Pressure in Patients With Normal Tension 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
- 32
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12
研究概览
简要总结
The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004% ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of normal tension glaucoma.
- •Must sign an Informed Consent form.
- •IOP within protocol-specified range.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Pregnant and lactating women, or women who intend to become pregnant during the study period.
- •Advanced and serious glaucoma, as specified in protocol.
- •Complicated chronic or recurrent uveitis, scleritis or corneal herpes.
- •History of ocular trauma, intraocular surgery or laser surgery for the included eye.
- •Ocular-infection and severe ocular complication.
- •Best-corrected visual acuity (BCVA) worse than 0.2 decimal.
- •Difficulty in conducting applanation tonometry for the included eye as determined by the doctor.
- •Severe or serious hypersensitivity to prostaglandin analogues or any ingredients used in the study.
- •Use of IOP lowering ophthalmic solutions other than TRAVATAN Z® or oral carbonic anhydrase inhibitor (Diamox, etc.) during the study period.
- •Use of any adrenocorticosteroids during the study period.
- •Use of IOP lowering ophthalmic solution within the past 30 days.
- •Regarded by doctor as not suitable for study participation.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
TRAVATAN Z
Experimental
Travoprost Ophthalmic Solution 0.004%, 1 drop instilled in each eye once daily at 9PM for 3 months.
干预措施: Travoprost Ophthalmic Solution 0.004% (Drug)
结局指标
主要结局
Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12
时间窗: Baseline (Day 0), Week 4, Week 8, Week 12
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis.
次要结局
未报告次要终点
研究者
研究点 (1)
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