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An Investigation of Topical Ophthalmic Low-Dose Atropine on Pupil Size and Accommodation

2026年6月23日 更新者:University of California, Berkeley

The goal of this clinical study is to learn about the short-term physiological effects of low-dose atropine in healthy volunteers. The study seeks to examine three questions related to low-dose topically applied ophthalmic atropine:

  1. Does applying two drops of 0.01% atropine sulfate solution cause the same clinical effects as one drop of 0.02% atropine?
  2. How quickly do the pupil responses and accommodative amplitudes recover following a dose of 0.01% atropine, 0.02% atropine, and 0.05% atropine?
  3. Does applying a single drop of 0.02% atropine sulfate solution cause the same clinical effects in participants with light vs. dark iris colors? Participants will have their pupil size and accommodative status measured at appropriate intervals to answer the questions above.

研究概览

研究类型

介入性

注册 (实际的)

24

阶段

  • 阶段1

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

    • California
      • Berkeley、California、美国、94720-2020
        • University of California, Berkeley

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

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Subjects may be male or female, of any race, and between 18-40 years old at the time of screening.
  2. Patients must have best spectacle corrected visual acuity of at least 0.10 logMAR (20/25) in each eye.
  3. Subjects must be willing and able to apply eye drops to their non-dominant eye and to return for all scheduled follow-up visits.

Exclusion Criteria:

  1. Subjects with any contraindication to atropine use (as listed on package insert). At the time of this submission, the only contraindication listed is: "Hypersensitivity or allergic reaction to any ingredient in formulation"
  2. Subjects using monamine oxidase inhibitors (MAOIs). These are: Isocarboxazid (Marplan), Phenelzine (Nardil), Selegiline (Emsam), and Tranylcypromine (Parnate).
  3. Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
  4. Subjects with a history of intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization >1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring). This includes any patient with open-angle glaucoma, regardless of medication regimen or control. Additionally, any patient with an intra-ocular pressure (IOP) greater than 21 mm Hg at baseline is specifically excluded from eligibility. Subjects with narrow angles (less than Van Herick angle of 3) will also be excluded.
  5. Subjects who are pregnant, planning to become pregnant or breastfeeding during the course of the study.

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:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Single drop of 0.02% atropine sulfate solution
Participants received one drop of 0.02% atropine sulfate solution in one eye.
One drop of 0.02% atropine sulfate solution
实验性的:Two drops of 0.01% atropine sulfate solution
Participants received two drops of 0.01% atropine sulfate solution in one eye, spaced five minutes apart.
Two drops of 0.01% atropine sulfate solution
其他:observation of pupil responses
Subjects will be observed until pupils fully recover from a single dose of one of the atropine concentrations used.
One drop of 0.02% atropine sulfate solution
Two drops of 0.01% atropine sulfate solution
Atropine 0.05% Ophthalmic Solution

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Minimum pupil size
大体时间:1-24 hours after drop application
Dynamic pupil responses to a single pulse of light were measured 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours after instilling the drop(s). The smallest pupil size (maximum pupil restriction) was used as the primary outcome measure.
1-24 hours after drop application

次要结果测量

结果测量
措施说明
大体时间
Accommodative Amplitude
大体时间:1-24 hours after drop application
Subjective accommodative response was measured via the pull-away AA method.
1-24 hours after drop application

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。

调查人员

  • 首席研究员:Sarah E Singh, OD, PhD、University of California, Berkeley

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 (实际的)

2022年3月16日

初级完成 (实际的)

2022年10月9日

研究完成 (实际的)

2022年10月9日

研究注册日期

首次提交

2026年6月23日

首先提交符合 QC 标准的

2026年6月23日

首次发布 (实际的)

2026年6月30日

研究记录更新

最后更新发布 (实际的)

2026年6月30日

上次提交的符合 QC 标准的更新

2026年6月23日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

All IPD variables, including data dictionaries, will be available to other researchers upon request to the principal investigator and completion of a signed data sharing agreement.

IPD 共享时间框架

As this study is being registered retroactively (and the study is complete), all data can be made available upon request at this time (March 2026).

IPD 共享访问标准

IPD can be accessed by emailing the PI who will make arrangements with appropriate UC Berkeley personnel to manage sharing.

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

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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