跳至主要内容
临床试验/NCT01735214
NCT01735214已完成不适用

An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments

Allergan0 个研究点目标入组 358 人开始时间: 2013年3月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Allergan
入组人数
358
主要终点
Change From Baseline in Intraocular Pressure (IOP) in the Left Eye

研究概览

简要总结

This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies with the physician according to their standard practice.

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

入选标准

  • Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT)
  • Previously prescribed any IOP-lowering therapy which has been stopped and a new prostaglandin analogue -containing IOP-lowering therapy started

排除标准

  • 未提供

研究组 & 干预措施

Patients with POAG or OHT

Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.

干预措施: Prostaglandin Analogue -Containing IOP-Lowering Therapy (Drug)

结局指标

主要结局

Change From Baseline in Intraocular Pressure (IOP) in the Left Eye

时间窗: Baseline, Week 12

IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.

Change From Baseline in Intraocular Pressure (IOP) in the Right Eye

时间窗: Baseline, Week 12

IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.

次要结局

  • Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale(12 Weeks)
  • Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale(12 Weeks)
  • Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks(12 Weeks)
  • Percentage of Participants Who Continue the New Treatment After 12 Weeks(12 Weeks)
  • Physician Assessment of Adherence to New Treatment Using a 4-Point Scale(12 Weeks)
  • Percentage of Participants Reaching Individual IOP Target After 12 Weeks(12 Weeks)
  • Physician Assessment of Efficacy Using a 5-Point Scale(12 Weeks)

研究者

发起方
Allergan
申办方类型
Industry
责任方
Sponsor

相似试验