NCT05199597

The Response to Atropine Drops (RAD) Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Myopia

Interventions

Type	Name	Description
DRUG	0.01% atropine	0.01%, room temp, Lab A
DRUG	0.05% atropine	0.05%, room temp, Lab A
DRUG	0.05% atropine	0.05%, refrigerated, Lab A
DRUG	0.05% atropine	0.05%, room temperature, Lab B

Timeline

• Start date: 2022-05-19
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2022-01-20
• Last updated: 2022-12-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study