The Response to Atropine Drops (RAD) Study

NCT05199597 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2021H0326
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Keywords

atropine

Outcome Measures

Primary Outcomes (1)

• 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)

  We will record comfort of each drop for a maximum of 25 seconds

Secondary Outcomes (6)

• Proportion Who Return to Baseline Comfort Within 25 Seconds

  We will record comfort of each drop for a maximum of 25 seconds

• Peak Comfort Score

  We will record comfort of each drop for a maximum of 25 seconds

• Average Comfort Score

  We will record comfort of each drop for a maximum of 25 seconds

• Correlation Between Peak Comfort Score and Corneal Sensitivity

  We will record comfort of the drop for a maximum of 25 seconds

• Correlation Between Peak Comfort Score and Iris Color

  We will record comfort of the drop for a maximum of 25 seconds

Study Arms (1)

All participants

EXPERIMENTAL

All participants will receive all four drops in randomized order

Drug: 0.01% atropine; Drug: 0.05% atropine

Interventions

0.01% atropine DRUG

0.01%, room temp, Lab A

Also known as: 0.01% atropine at room temperature from Lab A

All participants

0.05% atropine DRUG

0.05%, room temp, Lab A

Also known as: 0.05% atropine at room temperature from Lab A

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older

You may not qualify if:

• None

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University College of Optometry

Columbus, Ohio, 43210-1240, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: The participant will not know which of the four drops is being administered in random order
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Research

Model Details: Participants will have one drop of low concentration atropine placed in one eye four different times in random order

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 20, 2022
• Study Start: May 19, 2022
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)