The Response to Atropine Drops (RAD) Study
Primary Purpose
Myopia
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
0.01% atropine
0.05% atropine
0.05% atropine
0.05% atropine
Sponsored by
About this trial
This is an interventional other trial for Myopia focused on measuring atropine
Eligibility Criteria
Inclusion Criteria:
- 18 years and older
Exclusion Criteria:
- None
Sites / Locations
- Ohio State University College of Optometry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All participants
Arm Description
All participants will receive all four drops in randomized order
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
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)
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)
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)
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)
Full Information
NCT ID
NCT05199597
First Posted
January 6, 2022
Last Updated
December 6, 2022
Sponsor
Ohio State University
1. Study Identification
Unique Protocol Identification Number
NCT05199597
Brief Title
The Response to Atropine Drops (RAD) Study
Official Title
The Response to Atropine Drops (RAD) Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the comfort of giving low concentration atropine eye drops.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
atropine
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
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)
Masking Description
The participant will not know which of the four drops is being administered in random order
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All participants
Arm Type
Experimental
Arm Description
All participants will receive all four drops in randomized order
Intervention Type
Drug
Intervention Name(s)
0.01% atropine
Other Intervention Name(s)
0.01% atropine at room temperature from Lab A
Intervention Description
0.01%, room temp, Lab A
Intervention Type
Drug
Intervention Name(s)
0.05% atropine
Other Intervention Name(s)
0.05% atropine at room temperature from Lab A
Intervention Description
0.05%, room temp, Lab A
Intervention Type
Drug
Intervention Name(s)
0.05% atropine
Other Intervention Name(s)
0.05% atropine refrigerated from Lab A
Intervention Description
0.05%, refrigerated, Lab A
Intervention Type
Drug
Intervention Name(s)
0.05% atropine
Other Intervention Name(s)
0.05% atropine at room temperature from Lab B
Intervention Description
0.05%, room temperature, Lab B
Primary Outcome Measure Information:
Title
Time to Return to Baseline Comfort
Description
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)
Time Frame
We will record comfort of each drop for a maximum of 25 seconds
Secondary Outcome Measure Information:
Title
Proportion Who Return to Baseline Comfort Within 25 Seconds
Description
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)
Time Frame
We will record comfort of each drop for a maximum of 25 seconds
Title
Peak Comfort Score
Description
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)
Time Frame
We will record comfort of each drop for a maximum of 25 seconds
Title
Average Comfort Score
Description
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)
Time Frame
We will record comfort of each drop for a maximum of 25 seconds
Title
Correlation Between Peak Comfort Score and Corneal Sensitivity
Description
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)
Time Frame
We will record comfort of the drop for a maximum of 25 seconds
Title
Correlation Between Peak Comfort Score and Iris Color
Description
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)
Time Frame
We will record comfort of the drop for a maximum of 25 seconds
Title
Correlation Between Peak Comfort Score and the Perceived Victim Scale Score
Description
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)
Time Frame
We will record comfort of the drop for a maximum of 25 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years and older
Exclusion Criteria:
None
Facility Information:
Facility Name
Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
I do not plan to share the data
Learn more about this trial
The Response to Atropine Drops (RAD) Study
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