The Response to Atropine Drops (RAD) Study

Myopia Clinical Trial

Official title:

The Response to Atropine Drops (RAD) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05199597
• Other study ID #: 2021H0326
• Status: Completed
• Phase: Early Phase 1
• Start date: May 19, 2022
• Est. completion date: June 15, 2022

Study information

• Verified date: December 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• 0.01% atropine
0.01%, room temp, Lab A
• 0.05% atropine
0.05%, room temp, Lab A
• 0.05% atropine
0.05%, refrigerated, Lab A
• 0.05% atropine
0.05%, room temperature, Lab B

Locations

Country	Name	City	State
United States	Ohio State University College of Optometry	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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