An Early Phase 1 interventional study of 0.01% atropine and 0.05% atropine in Myopia, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by Ohio State University · Early Phase 1, Interventional, and Other
The purpose of this study is to examine the comfort of giving low concentration atropine eye drops.
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).
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants will receive all four drops in randomized order
Drug: 0.01% atropine · Drug: 0.05% atropine
0.01%, room temp, Lab A
Also known as: 0.01% atropine at room temperature from Lab A
0.05%, room temp, Lab A
Also known as: 0.05% atropine at room temperature from Lab A
0.05%, refrigerated, Lab A
Also known as: 0.05% atropine refrigerated from Lab A
0.05%, room temperature, Lab B
Also known as: 0.05% atropine at room temperature from Lab B
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: 1. 0.01% at room temperature from Lab A and 0.05% at room temperature from Lab A (comparing concentrations) 2. 0.05% at room temperature from Lab A and 0.05% refrigerated from Lab A (comparing temperatures) 3. 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
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: 1. 0.01% at room temperature from Lab A and 0.05% at room temperature from Lab A (comparing concentrations) 2. 0.05% at room temperature from Lab A and 0.05% refrigerated from Lab A (comparing temperatures) 3. 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
Peak Comfort Score
We will compare the peak comfort score, meaning the most discomfort, for the following drop comparisons: 1. 0.01% at room temperature from Lab A and 0.05% at room temperature from Lab A (comparing concentrations) 2. 0.05% at room temperature from Lab A and 0.05% refrigerated from Lab A (comparing temperatures) 3. 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
Average Comfort Score
We will compare the average comfort score over 25 seconds for the following drop comparisons: 1. 0.01% at room temperature from Lab A and 0.05% at room temperature from Lab A (comparing concentrations) 2. 0.05% at room temperature from Lab A and 0.05% refrigerated from Lab A (comparing temperatures) 3. 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
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)
Time frame: 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)
Time frame: 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)
Time frame: We will record comfort of the drop for a maximum of 25 seconds
Plan to share: No — I do not plan to share the data
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Ohio State University