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临床试验/NCT05199597
NCT05199597已完成早期 1 期

The Response to Atropine Drops (RAD) Study

Ohio State University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年5月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Time to Return to Baseline Comfort

研究概览

简要总结

The purpose of this study is to examine the comfort of giving low concentration atropine eye drops.

详细描述

After being informed about the study and potential risks, all participants giving written informed consent will answer questions about themselves and complete a 12-question survey about the need for drama. An examiner will then measure the sensitivity of the cornea (clear window on the front of the eye) by touching the cornea with a thin thread that shortens until it is first detected by the participant. After that, an examiner will place a drop of atropine in the right eye, and the participant will rate the eye comfort for 25 seconds using a computerized slide scale. Five minutes after the first drop, the examiner will put a drop in the left eye and the participant will rate the comfort for 25 seconds. The examiner will then repeat that process one more time with each eye. The drops placed in the eyes will be 0.01% atropine at room temperature from Lab A, 0.05% atropine at room temperature from Lab A, 0.05% atropine refrigerated from Lab A, or 0.05% atropine at room temperature from Lab B. The drops will be placed in the eyes in random order, so the participant won't know which one is being administered. At the very end, the participant will rate how likely s/he would be to take a low concentration atropine eye drop every day in each eye if it may delay the onset of nearsightedness from 1 (definitely not) to 10 (definitely would).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Other
盲法
None

盲法说明

The participant will not know which of the four drops is being administered in random order

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

  • 18 years and older

排除标准

  • 未提供

研究组 & 干预措施

All participants

Experimental

All participants will receive all four drops in randomized order

干预措施: 0.01% atropine (Drug)

All participants

Experimental

All participants will receive all four drops in randomized order

干预措施: 0.05% atropine (Drug)

结局指标

主要结局

Time to Return to Baseline Comfort

时间窗: We will record comfort of each drop for a maximum of 25 seconds

We will compare the amount of time that it takes a participant to report that the eye comfort is "0," meaning that it returned to baseline comfort, for the following drop comparisons: 1. 0.01% at room temperature from Lab A and 0.05% at room temperature from Lab A (comparing concentrations) 2. 0.05% at room temperature from Lab A and 0.05% refrigerated from Lab A (comparing temperatures) 3. 0.05% at room temperature from Lab A and 0.05% at room temperature from Lab B (comparing labs)

次要结局

  • Proportion Who Return to Baseline Comfort Within 25 Seconds(We will record comfort of each drop for a maximum of 25 seconds)
  • Correlation Between Peak Comfort Score and the Perceived Victim Scale Score(We will record comfort of the drop for a maximum of 25 seconds)
  • Average Comfort Score(We will record comfort of each drop for a maximum of 25 seconds)
  • Correlation Between Peak Comfort Score and Iris Color(We will record comfort of the drop for a maximum of 25 seconds)
  • Peak Comfort Score(We will record comfort of each drop for a maximum of 25 seconds)
  • Correlation Between Peak Comfort Score and Corneal Sensitivity(We will record comfort of the drop for a maximum of 25 seconds)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey J. Walline, OD PhD

Associate Dean for Research

Ohio State University

研究点 (1)

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