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Completed

NCT Number: NCT05199597

The Response to Atropine Drops (RAD) Study

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ohio State University College of Optometry

Columbus, Ohio, 43210-1240, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years and older

Exclusion criteria

  • None

Treatment and study plan

0.01% atropine

Drug

0.01%, room temp, Lab A

Other names: 0.01% atropine at room temperature from Lab A

0.05% atropine

Drug

0.05%, room temp, Lab A

Other names: 0.05% atropine at room temperature from Lab A

Primary outcomes

  1. Time to Return to Baseline Comfort

    Time frame: 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:

    • 0.01% at room temperature from Lab A and 0.05% at room temperature from Lab A (comparing concentrations)
    • 0.05% at room temperature from Lab A and 0.05% refrigerated from Lab A (comparing temperatures)
    • 0.05% at room temperature from Lab A and 0.05% at room temperature from Lab B (comparing labs)

Secondary outcomes

  1. Proportion Who Return to Baseline Comfort Within 25 Seconds

    Time frame: We will record comfort of each drop for a maximum of 25 seconds

    We will compare the proportion of participants who report the eye comfort is "0," meaning that it returned to baseline comfort, for the following drop comparisons:

    • 0.01% at room temperature from Lab A and 0.05% at room temperature from Lab A (comparing concentrations)
    • 0.05% at room temperature from Lab A and 0.05% refrigerated from Lab A (comparing temperatures)
    • 0.05% at room temperature from Lab A and 0.05% at room temperature from Lab B (comparing labs) Comfort scale ranges from 0 (no discomfort) to 10 (extreme discomfort)

  2. Peak Comfort Score

    Time frame: We will record comfort of each drop for a maximum of 25 seconds

    We will compare the peak comfort score, meaning the most discomfort, for the following drop comparisons:

    • 0.01% at room temperature from Lab A and 0.05% at room temperature from Lab A (comparing concentrations)
    • 0.05% at room temperature from Lab A and 0.05% refrigerated from Lab A (comparing temperatures)
    • 0.05% at room temperature from Lab A and 0.05% at room temperature from Lab B (comparing labs) Comfort scale ranges from 0 (no discomfort) to 10 (extreme discomfort)

  3. Average Comfort Score

    Time frame: We will record comfort of each drop for a maximum of 25 seconds

    We will compare the average comfort score over 25 seconds for the following drop comparisons:

    • 0.01% at room temperature from Lab A and 0.05% at room temperature from Lab A (comparing concentrations)
    • 0.05% at room temperature from Lab A and 0.05% refrigerated from Lab A (comparing temperatures)
    • 0.05% at room temperature from Lab A and 0.05% at room temperature from Lab B (comparing labs) Comfort scale ranges from 0 (no discomfort) to 10 (extreme discomfort)

  4. Correlation Between Peak Comfort Score and Corneal Sensitivity

    Time frame: We will record comfort of the drop for a maximum of 25 seconds

    We will determine the correlation coefficient between the peak pain score when taking 0.05% atropine at room temperature from Lab A and corneal sensitivity Comfort scale ranges from 0 (no discomfort) to 10 (extreme discomfort)

  5. Correlation Between Peak Comfort Score and Iris Color

    Time frame: We will record comfort of the drop for a maximum of 25 seconds

    We will determine the correlation coefficient between the peak pain score when taking 0.05% atropine at room temperature from Lab A and iris color Comfort scale ranges from 0 (no discomfort) to 10 (extreme discomfort)

  6. Correlation Between Peak Comfort Score and the Perceived Victim Scale Score

    Time frame: We will record comfort of the drop for a maximum of 25 seconds

    We will determine the correlation coefficient between the peak pain score when taking 0.05% atropine at room temperature from Lab A and the Persistent Perceived Victim scale score of the Need for Drama Survey Comfort scale ranges from 0 (no discomfort) to 10 (extreme discomfort)

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2022
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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