NCT00486252已完成不适用
Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN® (Latanoprost) as First-Line Monotherapy and as Second-Line Monotherapy After Beta-Blockers Therapy Failure
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点目标入组 996 人开始时间: 2007年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 996
- 主要终点
- Change in Intraocular Pressure (IOP): Baseline to Month 3
研究概览
简要总结
The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over 3 months. The secondary objective is to study the other efficacy parameters during treatment for 3 months
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Unilateral or bilateral open angle glaucoma or ocular hypertension (IOP (Intraocular Pressure) ≥ 21 mmHg at diagnosis).
- •Naive patients (no prior anti-glaucoma pharmacological or surgical treatment) and patients with beta-blockers therapy failure
- •Visual acuity (best corrected) equal to or better than 6/6
排除标准
- •closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
- •history of any antiglaucoma surgical treatment (Argon Laser Trabeculoplasty and/or any ocular filtering surgical intervention).
- •ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to baseline visit. (Applies to both fellow and study eyes.)
- •other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.
结局指标
主要结局
Change in Intraocular Pressure (IOP): Baseline to Month 3
时间窗: Baseline, Month 3
Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between the eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.
次要结局
- Percentage Change in Intraocular Pressure (IOP)(Month 1, Month 3)
- Categorized Percentage Change in Intraocular Pressure (IOP)(Month 1, Month 3)
研究者
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