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临床试验/NCT00803803
NCT00803803已完成4 期

Dose, Effects and Characteristics of Pilocarpine

Wills Eye1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2008年12月8日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
37
试验地点
1
主要终点
Intraocular Pressure

研究概览

简要总结

The purpose of this investigation, in which pilocarpine was given in repeated doses, was to evaluate: Part I - the effects of different concentrations of pilocarpine hydrochloride on intraocular pressure. Part II -the effects on intraocular pressure of glaucomatous patients to pilocarpine 2% when given once, twice and four daily. In addition, we studied various attributes of the eye which may serve as indicators of responsiveness of individual patients to pilocarpine.

详细描述

In addition, we studied various attributes of the eye which may serve as indicators of responsiveness of individual patients to pilocarpine.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary open-angle glaucoma
  • Primary open-angle glaucoma suspect

排除标准

  • 未提供

研究组 & 干预措施

Pilocarpine Concentration

Experimental

Varying concentration 0.5 to 8% - 22 patients were examined regarding: visual acuity, iris color, pupil size, chamber angle, C/D ratio, visual field (VF), coefficient of aqueous outflow and Goldmann tonometry. After a one month washout period, pilocarpine was used 4 times daily, in concentrations from 0.5 to 8%. The amount of IOP change was compared with various clinical findings

干预措施: Pilocarpine Concentration (Drug)

Pilocarpine Frequency

Experimental

Varying frequency, once to four times daily - 15 patients were included in a crossover study: IOP was checked daily for 3 days and for 9 hours on fourth day. Pilocarpine was started on day 5 once daily OD and BID OS; on day 9 once daily OD and QID OS; on day 12 QID OD and once daily OS; on day 16 once daily OD and QID OS; and on day 19 QID OD and once daily OS. No medications were used on days 23-25. IOP was measured on days 4, 8, 11, 15, 18, 22 and 25.

干预措施: Pilocarpine Frequency (Drug)

结局指标

主要结局

Intraocular Pressure

时间窗: 25 days

次要结局

未报告次要终点

研究者

发起方
Wills Eye
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marlene Moster, MD

Attending Surgeon

Wills Eye

研究点 (1)

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