跳至主要内容
临床试验/NCT00823043
NCT00823043已完成不适用

A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With Timolol Hemihydrate 0.5% Solution Once or Twice Daily Versus Timolol Maleate in Sorbate

Vistakon Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2009年1月最近更新:
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
入组人数
103
试验地点
1
主要终点
Subject Reported Burning/Stinging

研究概览

简要总结

The objective of the study was to evaluate whether timolol hemihydrate is more comfortable upon instillation than timolol maleate in sorbate. This was an observational study. Subjects with open-angle glaucoma or ocular hypertension were asked to complete a survey regarding their normal treatment. No treatment was prescribed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • willing to comply with investigator's and protocol's instructions
  • patients signature on the informed consent document
  • open-angle glaucoma or ocular hypertension
  • currently prescribed timolol hemihydrate (once a day (QD) or twice a day (BID))or timolol maleate in sorbate QD as monotherapy or as a part of 2-drug therapy in at least one eye

排除标准

  • inability to understand the trial procedures
  • inability to give informed consent
  • inability to understand, read, or write English
  • best corrected visual acuity of 20/200 or worse in each eye
  • current moderate to severe infectious or inflammatory condition of the eye or eyelids including
  • current moderate to severe dry eye syndrome
  • current chronic use of ocular corticosteroids, ocular surgery or intraocular laser surgery to either eye in the prior 3 months
  • treated with 3 or more glaucoma medicines in both eye

研究组 & 干预措施

Timolol hemihydrate

Subjects currently prescribed timolol hemihydrate 0.5% solution.

干预措施: timolol hemihydrate (Drug)

Timolol maleate

Subjects currently prescribed timolol maleate in sorbate.

干预措施: timolol maleate (Drug)

结局指标

主要结局

Subject Reported Burning/Stinging

时间窗: Upon instillation

Subjects reported burning/stinging after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

Subject Reported Tearing

时间窗: Upon instillation.

Subjects reported tearing after they put the drops in their eyes using the following scale:0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

Subject Reported Light Sensitivity

时间窗: Upon instillation

Subjects reported light hurt their eyes after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

Subject Reported Blurred Vision

时间窗: Upon instillation

Subjects reported their vision was blurred after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

次要结局

未报告次要终点

研究者

发起方
Vistakon Pharmaceuticals
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验