Clinical trial NCT05199597: The Response to Atropine Drops (RAD) Study
Official title: The Response to Atropine Drops (RAD) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Myopia
Keywords: atropine
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Participants will have one drop of low concentration atropine placed in one eye four different times in random order
Primary purpose: OTHER

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).

Eligibility criteria: Inclusion Criteria:

* 18 years and older

Exclusion Criteria:

* None

Primary outcomes:
measure: Time to Return to Baseline Comfort
timeFrame: We will record comfort of each drop for a maximum of 25 seconds
Secondary outcomes:
measure: Proportion Who Return to Baseline Comfort Within 25 Seconds
timeFrame: We will record comfort of each drop for a maximum of 25 seconds
measure: Peak Comfort Score
timeFrame: We will record comfort of each drop for a maximum of 25 seconds
measure: Average Comfort Score
timeFrame: We will record comfort of each drop for a maximum of 25 seconds
measure: Correlation Between Peak Comfort Score and Corneal Sensitivity
timeFrame: We will record comfort of the drop for a maximum of 25 seconds
measure: Correlation Between Peak Comfort Score and Iris Color
timeFrame: We will record comfort of the drop for a maximum of 25 seconds
measure: Correlation Between Peak Comfort Score and the Perceived Victim Scale Score
timeFrame: We will record comfort of the drop for a maximum of 25 seconds
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University College of Optometry
state: Ohio
Study officials:
References: