MyopiaEarly Phase 1NCT05199597
The Response to Atropine Drops (RAD) Study
A Early Phase 1 study testing 0.01% atropine and 0.05% atropine in people with Myopia, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to examine the comfort of giving low concentration atropine eye drops. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- 0.01% atropine and 0.05% atropine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2022to 15 Jun 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University College of Optometry
Columbus, Ohio, 43210-1240
About this study
The purpose of this study is to examine the comfort of giving low concentration atropine eye drops.
Read the 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
- Being tested
- 0.01% atropine, 0.05% atropine
- Keywords
- atropine
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.01% atropineDrug
Also called 0.01% atropine at room temperature from Lab A
0.01%, room temp, Lab A
0.05% atropineDrug
Also called 0.05% atropine at room temperature from Lab A
0.05%, room temp, Lab A
0.05% atropineDrug
Also called 0.05% atropine refrigerated from Lab A
0.05%, refrigerated, Lab A
0.05% atropineDrug
Also called 0.05% atropine at room temperature from Lab B
0.05%, room temperature, Lab B
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will receive all four drops in randomized order Receives: Drug: 0.01% atropine; Drug: 0.05% atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 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)
Measured: 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:
- 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)
Measured: 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:
- 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: We will record comfort of the drop for a maximum of 25 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start19 May 2022
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey J. Walline, OD PhD, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199597
- Sponsor's protocol ID
- 2021H0326
- Status last verified
- Dec 2022
- First submitted
- 6 Jan 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: I do not plan to share the data
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Response to Atropine Drops (RAD) Study
- ClinicalTrials.gov ID
- NCT05199597
- Acronym / sponsor ID
- 2021H0326
- Conditions
- Myopia
- Keywords
- atropine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will have one drop of low concentration atropine placed in one eye four different times in random order
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Drug: 0.01% atropine, Drug: 0.05% atropineAll participants will receive all four drops in randomized order |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years and older
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.01% atropineAlso: 0.01% atropine at room temperature from Lab A0.01%, room temp, Lab A | Drug | All participants |
| 0.05% atropineAlso: 0.05% atropine at room temperature from Lab A0.05%, room temp, Lab A | Drug | All participants |
| 0.05% atropineAlso: 0.05% atropine refrigerated from Lab A0.05%, refrigerated, Lab A | Drug | All participants |
| 0.05% atropineAlso: 0.05% atropine at room temperature from Lab B0.05%, room temperature, Lab B | Drug | All participants |
Primary outcome
Time to Return to Baseline Comfort
Time frame: We will record comfort of each drop for a maximum of 25 seconds
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)
6 secondary outcomes
Proportion Who Return to Baseline Comfort Within 25 Seconds
Time frame: We will record comfort of each drop for a maximum of 25 seconds
Peak Comfort Score
Time frame: We will record comfort of each drop for a maximum of 25 seconds
Average Comfort Score
Time frame: We will record comfort of each drop for a maximum of 25 seconds
Correlation Between Peak Comfort Score and Corneal Sensitivity
Time frame: We will record comfort of the drop for a maximum of 25 seconds
Correlation Between Peak Comfort Score and Iris Color
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
Time frame: We will record comfort of the drop for a maximum of 25 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: No. I do not plan to share the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 0.01% atropine and 0.05% atropine in people with Myopia, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Return to Baseline Comfort (time frame: We will record comfort of each drop for a maximum of 25 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.