The Response to Atropine Drops (RAD) Study

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Drug: 0.01% atropine; Drug: 0.05% atropine; Drug: 0.05% atropine; Drug: 0.05% atropine

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210-1240
      • Ohio State University College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years and older

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All participants; All participants will receive all four drops in randomized order

Drug: 0.01% atropine; 0.01%, room temp, Lab A; Other Names: 0.01% atropine at room temperature from Lab A; Drug: 0.05% atropine; 0.05%, room temp, Lab A; Other Names: 0.05% atropine at room temperature from Lab A; Drug: 0.05% atropine; 0.05%, refrigerated, Lab A; Other Names: 0.05% atropine refrigerated from Lab A; Drug: 0.05% atropine; 0.05%, room temperature, Lab B; Other Names: 0.05% atropine at room temperature from Lab B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Return to Baseline Comfort	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)	We will record comfort of each drop for a maximum of 25 seconds

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: atropine
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: 2021H0326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: I do not plan to share the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No