MyopiaPhase 1/2SEANCT03593044
Side Effects of Atropine (SEA) Study
A Phase 1/2 study testing 0.01% concentration atropine drops in people with Myopia, run by Jeffrey J. Walline, OD PhD at 1 site in United States.
Trial summary
This study will perform several objective and subjective measurements of the eye and vision before and after a week of using 0.01% concentration atropine drops. These measurements will help to obtain a comprehensive understanding of the side effects of this concentration of atropine and determine if the drops would be… Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- 0.01% concentration atropine drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2018to 17 Jan 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -N/A
Who cannot join
- Outside of age range
- History of accommodative (focusing) issues or therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University College of Optometry
Columbus, Ohio, 43210
About this study
This study will perform several objective and subjective measurements of the eye and vision before and after a week of using 0.01% concentration atropine drops. These measurements will help to obtain a comprehensive understanding of the side effects of this concentration of atropine and determine if the drops would be tolerated as a possible preventative treatment for nearsightedness.
Read the detailed description
Atropine drops are commonly used to dilate the eye and prevent the ability to focus and also slow the progression of nearsightedness. Low concentration (0.01%) atropine slows the progression of myopia 60% to 83% while causing less side effects than high concentration (1.0%) atropine though still showing an effect on pupil size and pupil response.This study is a prospective cohort study in which several objective and subjective measurements will be taken before and after the use of 0.01% atropine for a week to determine the effect of this concentration on 1. vision at distance and near; 2. pupil size; 3. focusing ability, accuracy, and change; 4. symptoms, including subjective vision, headaches, light sensitivity, drop comfort; and 5. pressure in the eye. This will allow us to determine the effect these drops have on the eye and whether or not patients would be willing to use them as a possible preventative treatment for nearsightedness. The investigators expect to find that the drops will not affect vision, will increase pupil size, decrease focusing ability and accuracy (but not clinically meaningfully), cause some light sensitivity, and have no effect on eye pressure. The investigators expect that patients would be willing to use these drops to control nearsightedness even after experiencing the side effects.
- Conditions
- Myopia
- Being tested
- 0.01% concentration atropine drops
- Keywords
- atropine, photophobia, pupil, reading speed, myopia, Surveys and Questionnaires
- Medical subject headings
- Myopia, Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.01% concentration atropine dropsDrug
Also called Atropine Sulfate
One drop of 0.01% concentration atropine in each eye at night for seven days.
| Study group | Role | What they receive |
|---|---|---|
| One Week Atropine | Experimental | 0.01% concentration atropine drops Receives: Drug: 0.01% concentration atropine drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of the Pupil Measured With a Neuroptix Pupillometer
Change in pupil size between baseline visit and follow up visit (after one week on treatment) in millimeters to the nearest tenth of a millimeter
Measured: Baseline (before) and one week after beginning treatment with drops
Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts
Investigators will measure the change in high contrast distance and near logMAR visual acuity and low contrast distance logMAR visual acuity between baseline visit and follow up visit (after one week on treatment).
Measured: Baseline (before) and one week after beginning treatment with drops
Secondary outcomes (4)
Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor
Investigators will measure the change in near point of accommodation (how close an object can be seen clearly) in centimeters and accommodative lag (error of focusing on near objects) in diopters.
Measured: One week after beginning treatment with drops
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Each of the below scores are from an individual question that was answered before taking atropine drops and after taking atropine drops nightly for one week.
Glare: 1 (good) to 10 (perfect); 10 is best Ghost images: 1 (good) to 10 (perfect); 10 is best Straing/tiredness: 1 (good) to 10 (perfect); 10 is best Changing vision: 1 (good) to 10 (perfect); 10 is best Headache frequency: 1 (very infrequent) to 10 (very frequent); 1 is best Distance clarity: 1 (good) to 10 (perfect): 10 is best Computer clarity: 1 (good) to 10 (perfect); 10 is best Small print clarity: 1 (good) to 10 (perfect); 10 is best Sports/hobbies vision: 1 (good) to 10 (perfect); 10 is best Overall vision: 1 (good) to 10 (perfect); 10 is best Light sensitivity: 1 (not sensitive at all) to 10 (very sensitive); 10 is best Discomfort during bright light: 1 (no discomfort) to 10 (extreme discomfort); 1 is best
Measured: Baseline (before) and one week after beginning treatment with drops
Change in Intraocular Pressure Using a Tonopen
We will measure the change in eye pressure between baseline visit and follow up visit (after one week on treatment) measured with Tonopen and recorded in mmHg.
Measured: Baseline (before) and one week after beginning treatment with drops
Ability to Change Focus From Far to Near Measured by Stimulating and Relaxing Focus of the Eyes as Many Times as Possible in One Minute.
Investigators will measure accommodative facility (ability to change focus from far to near) in number of cycles between baseline visit and follow up visit (after one week on treatment).
Measured: Baseline (before) and one week after beginning treatment with drops
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start23 Jul 2018
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will take drops for one week and measurements will be taken before and after treatment period.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey J. Walline, OD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey J. Walline, OD PhD, Ohio State University
- Investigators
- Jeffrey Walline, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593044
- Sponsor's protocol ID
- 2018H0224
- Acronym
- SEA
- Status last verified
- Nov 2022
- First submitted
- 27 Jun 2018
- Last updated
- 2 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chia A, Chua WH, Cheung YB, Wong WL, Lingham A, Fong A, Tan D. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology. 2012 Feb;119(2):347-54. doi: 10.1016/j.ophtha.2011.07.031. Epub 2011 Oct 2.
PubMed 21963266Clark TY, Clark RA. Atropine 0.01% Eyedrops Significantly Reduce the Progression of Childhood Myopia. J Ocul Pharmacol Ther. 2015 Nov;31(9):541-5. doi: 10.1089/jop.2015.0043. Epub 2015 Jul 28.
PubMed 26218150
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side Effects of Atropine (SEA) Study
- ClinicalTrials.gov ID
- NCT03593044
- Acronym / sponsor ID
- SEA / 2018H0224
- Conditions
- Myopia
- Keywords
- atropine, photophobia, pupil, reading speed, myopia, Surveys and Questionnaires
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Jeffrey J. Walline, OD PhDUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Posted 2 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will perform several objective and subjective measurements of the eye and vision before and after a week of using 0.01% concentration atropine drops. These measurements will help to obtain a comprehensive understanding of the side effects of this concentration of atropine and determine if the drops would be tolerated as a possible preventative treatment for nearsightedness.
Detailed description
Atropine drops are commonly used to dilate the eye and prevent the ability to focus and also slow the progression of nearsightedness. Low concentration (0.01%) atropine slows the progression of myopia 60% to 83% while causing less side effects than high concentration (1.0%) atropine though still showing an effect on pupil size and pupil response.This study is a prospective cohort study in which several objective and subjective measurements will be taken before and after the use of 0.01% atropine for a week to determine the effect of this concentration on 1. vision at distance and near; 2. pupil size; 3. focusing ability, accuracy, and change; 4. symptoms, including subjective vision, headaches, light sensitivity, drop comfort; and 5. pressure in the eye. This will allow us to determine the effect these drops have on the eye and whether or not patients would be willing to use them as a possible preventative treatment for nearsightedness. The investigators expect to find that the drops will not affect vision, will increase pupil size, decrease focusing ability and accuracy (but not clinically meaningfully), cause some light sensitivity, and have no effect on eye pressure. The investigators expect that patients would be willing to use these drops to control nearsightedness even after experiencing the side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will take drops for one week and measurements will be taken before and after treatment period.
| Arm | Type | Receives |
|---|---|---|
| One Week Atropine | Experimental | Drug: 0.01% concentration atropine drops0.01% concentration atropine drops |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -N/A
Key exclusion criteria (2 listed)
- Outside of age range
- History of accommodative (focusing) issues or therapy
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% concentration atropine dropsAlso: Atropine SulfateOne drop of 0.01% concentration atropine in each eye at night for seven days. | Drug | One Week Atropine |
Primary outcome
Diameter of the Pupil Measured With a Neuroptix Pupillometer
Time frame: Baseline (before) and one week after beginning treatment with drops
Change in pupil size between baseline visit and follow up visit (after one week on treatment) in millimeters to the nearest tenth of a millimeter
Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts
Time frame: Baseline (before) and one week after beginning treatment with drops
Investigators will measure the change in high contrast distance and near logMAR visual acuity and low contrast distance logMAR visual acuity between baseline visit and follow up visit (after one week on treatment).
4 secondary outcomes
Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor
Time frame: One week after beginning treatment with drops
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Time frame: Baseline (before) and one week after beginning treatment with drops
Change in Intraocular Pressure Using a Tonopen
Time frame: Baseline (before) and one week after beginning treatment with drops
Ability to Change Focus From Far to Near Measured by Stimulating and Relaxing Focus of the Eyes as Many Times as Possible in One Minute.
Time frame: Baseline (before) and one week after beginning treatment with drops
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21963266Chia A, Chua WH, Cheung YB, Wong WL, Lingham A, Fong A, Tan D. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology. 2012 Feb;119(2):347-54. doi: 10.1016/j.ophtha.2011.07.031. Epub 2011 Oct 2.
- Background: PubMed 26218150Clark TY, Clark RA. Atropine 0.01% Eyedrops Significantly Reduce the Progression of Childhood Myopia. J Ocul Pharmacol Ther. 2015 Nov;31(9):541-5. doi: 10.1089/jop.2015.0043. Epub 2015 Jul 28.
- Individual participant dataSharing planned: No
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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.
Jeffrey Walline principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 0.01% concentration atropine drops in people with Myopia, run by Jeffrey J. Walline, OD PhD 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 2 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 2 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diameter of the Pupil Measured With a Neuroptix Pupillometer (time frame: Baseline (before) and one week after beginning treatment with drops). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03593044, which also lists 2 linked publications.
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 2 Dec 2022.