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Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

2011年4月28日 更新者：Nanduri, Padma, M.D., FACS

Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy

The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular pressure (IOP) utilizing an experimental lotion containing 0.1% Brimonidine that is applied to the outside of one eyelid.

研究概览

地位

未知

条件

干预/治疗

详细说明

Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma the most common form of glaucoma. Vision loss is caused by damage to the optic nerve. The modern goals of glaucoma management are to avoid glaucomatous damage, nerve damage, preserve visual field and total quality of life for patients with minimal side effects.

Although intraocular pressure is only one of the major risk factors for glaucoma, lowering it via various pharmaceuticals and/or surgical techniques is currently the mainstay of glaucoma treatment. Intraocular pressure can be lowered with medication, usually eye drops. There are several different classes of medications to treat glaucoma with several different medications in each class. In order to prevent blindness from glaucoma, it is critical that patients take their glaucoma eye drops accurately and faithfully for the rest of their lives. Poor compliance with medications and follow-up visits is a major reason for vision loss in glaucoma patients. In addition, coordination involved in placing an eye drop in the eye is considerably more difficult and unpleasant to patients than many other therapies. Thus, localized transdermal eyelid lotion would create a leap in safety of drug delivery while at the same time rendering ocular drugs easy and non traumatic to use.

研究类型

介入性

注册 (预期的)

22

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Visalia、California、美国、93277
        • 招聘中
        • Eye Surgical and Medical Associates
        • 接触：
        • 接触：
        • 副研究员：
          • Michael Boone, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable Vital signs who are controlled on a stable dose of a single IOP lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months.
  • Male or Female patients aged at least 18 years of age.
  • Females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms.
  • A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of childbearing potential
  • Best-Corrected Visual Acuity of 20/800 or better in both eyes
  • Written informed consent.
  • Ability to follow instructions and likely to complete all study visits based upon patient factors such as cognition, reliability, motivation, and ability to obtain reliable transportation to study site.

Exclusion Criteria:

  • Uncontrolled glaucoma
  • Glaucoma requiring more than a single agent for IOP control
  • Patients with a corneal thickness greater then 620 micrometers
  • Female patients who are pregnant, nursing, or planning a pregnancy during the study
  • Patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study
  • Uncontrolled or labile hypertension
  • At the conclusion of the washout period any study participant with an IOP lower than 22 or greater than 35 mmHg.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Intraocular Pressure
大体时间：Day one, every hour for twelve hours.
Day one, every hour for twelve hours.
Heart Rate
大体时间：Day one, every hour for twelve hours.
Day one, every hour for twelve hours.
Blood Pressure
大体时间：Day one, every hour for twelve hours.
Day one, every hour for twelve hours.
Intraocular Pressure
大体时间：Day two twice, once in the AM, once in the PM.
Day two twice, once in the AM, once in the PM.
Intraocular Pressure
大体时间：Day seven, once.
Day seven, once.
Intraocular Pressure
大体时间：Day fourteen, once.
Day fourteen, once.
Intraocular Pressure
大体时间：Day twenty one, once.
Day twenty one, once.
Intraocular Pressure
大体时间：Day twenty eight, once.
Day twenty eight, once.
Heart Rate
大体时间：Day two twice, once in the AM, once in the PM.
Day two twice, once in the AM, once in the PM.
Heart Rate
大体时间：Day seven, once.
Day seven, once.
Heart Rate
大体时间：Day fourteen, once.
Day fourteen, once.
Heart Rate
大体时间：Day twenty one, once.
Day twenty one, once.
Heart Rate
大体时间：Day twenty eight, once.
Day twenty eight, once.
Blood Pressure
大体时间：Day two twice, once in the AM, once in the PM.
Day two twice, once in the AM, once in the PM.
Blood Pressure
大体时间：Day seven, once.
Day seven, once.
Blood Pressure
大体时间：Day fourteen, once.
Day fourteen, once.
Blood Pressure
大体时间：Day twenty one, once.
Day twenty one, once.
Blood Pressure
大体时间：Day twenty eight, once.
Day twenty eight, once.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nanduri, Padma, M.D., FACS

调查人员

  • 首席研究员：Padma Nanduri, MD
  • 研究主任：Michael Boone, MD

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年4月1日

初级完成 (预期的)

2011年7月1日

研究完成 (预期的)

2011年7月1日

研究注册日期

首次提交

2011年4月27日

首先提交符合 QC 标准的

2011年4月28日

首次发布 (估计)

2011年5月2日

研究记录更新

最后更新发布 (估计)

2011年5月2日

上次提交的符合 QC 标准的更新

2011年4月28日

最后验证

2011年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • White Rabbit 2010-0001

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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