The Response to Atropine Drops (RAD) Study

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

Detailed Description
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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).

Official Title
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The Response to Atropine Drops (RAD) Study

Conditions
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Myopia

Intervention / Treatment
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* Drug: 0.01% atropine
* Drug: 0.05% atropine
* Drug: 0.05% atropine
* Drug: 0.05% atropine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Interventional Model Description: Participants will have one drop of low concentration atropine placed in one eye four different times in random order
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All participants<br>All participants will receive all four drops in randomized order | Drug: 0.01% atropine<br>* 0.01%, room temp, Lab A<br>* Other names: 0.01% atropine at room temperature from Lab A;Drug: 0.05% atropine<br>* 0.05%, room temp, Lab A<br>* Other names: 0.05% atropine at room temperature from Lab A;Drug: 0.05% atropine<br>* 0.05%, refrigerated, Lab A<br>* Other names: 0.05% atropine refrigerated from Lab A;Drug: 0.05% atropine<br>* 0.05%, room temperature, Lab B<br>* Other names: 0.05% atropine at room temperature from Lab B;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atropine