MyopiaPhase 1NCT07674966
An Investigation of Topical Ophthalmic Low-Dose Atropine on Pupil Size and Accommodation
A Phase 1 study testing Atropine 0.01% Ophthalmic Solution, Atropine 0.02% Ophthalmic Solution and Atropine 0.05% Ophthalmic Solution in people with Myopia, run by University of California, Berkeley at 1 site in United States.
Trial summary
The goal of this clinical study is to learn about the short-term physiological effects of low-dose atropine in healthy volunteers. The study seeks to examine three questions related to low-dose topically applied ophthalmic atropine: 1. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine 0.01% Ophthalmic Solution, Atropine 0.02% Ophthalmic Solution and Atropine 0.05% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2022to 9 Oct 2022
- Phase
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects may be male or female, of any race, and between 18-40 years old at the time of screening.
- Patients must have best spectacle corrected visual acuity of at least 0.10 logMAR (20/25) in each eye.
- Subjects must be willing and able to apply eye drops to their non-dominant eye and to return for all scheduled follow-up visits.
Who cannot join
- Subjects with any contraindication to atropine use (as listed on package insert). At the time of this submission, the only contraindication listed is: "Hypersensitivity or allergic reaction to any ingredient in formulation"
- Subjects using monamine oxidase inhibitors (MAOIs). These are: Isocarboxazid (Marplan), Phenelzine (Nardil), Selegiline (Emsam), and Tranylcypromine (Parnate).
- Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
- Subjects with a history of intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization >1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring). This includes any patient with open-angle glaucoma, regardless of medication regimen or control. Additionally, any patient with an intra-ocular pressure (IOP) greater than 21 mm Hg at baseline is specifically excluded from eligibility. Subjects with narrow angles (less than Van Herick angle of 3) will also be excluded.
- Subjects who are pregnant, planning to become pregnant or breastfeeding during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720-2020
About this study
The goal of this clinical study is to learn about the short-term physiological effects of low-dose atropine in healthy volunteers. The study seeks to examine three questions related to low-dose topically applied ophthalmic atropine:
- Does applying two drops of 0.01% atropine sulfate solution cause the same clinical effects as one drop of 0.02% atropine?
- How quickly do the pupil responses and accommodative amplitudes recover following a dose of 0.01% atropine, 0.02% atropine, and 0.05% atropine?
- Does applying a single drop of 0.02% atropine sulfate solution cause the same clinical effects in participants with light vs. dark iris colors? Participants will have their pupil size and accommodative status measured at appropriate intervals to answer the questions above.
- Conditions
- Myopia
- Being tested
- Atropine 0.01% Ophthalmic Solution, Atropine 0.02% Ophthalmic Solution, Atropine 0.05% Ophthalmic Solution
- Keywords
- myopia, atropine
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine 0.01% Ophthalmic SolutionDrug
Two drops of 0.01% atropine sulfate solution
Atropine 0.02% Ophthalmic SolutionDrug
One drop of 0.02% atropine sulfate solution
Atropine 0.05% Ophthalmic SolutionDrug
Atropine 0.05% Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| Single drop of 0.02% atropine sulfate solution | Experimental | Participants received one drop of 0.02% atropine sulfate solution in one eye. Receives: Drug: Atropine 0.02% Ophthalmic Solution |
| Two drops of 0.01% atropine sulfate solution | Experimental | Participants received two drops of 0.01% atropine sulfate solution in one eye, spaced five minutes apart. Receives: Drug: Atropine 0.01% Ophthalmic Solution |
| observation of pupil responses | Other | Subjects will be observed until pupils fully recover from a single dose of one of the atropine concentrations used. Receives: Drug: Atropine 0.01% Ophthalmic Solution; Drug: Atropine 0.02% Ophthalmic Solution; Drug: Atropine 0.05% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum pupil size
Dynamic pupil responses to a single pulse of light were measured 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours after instilling the drop(s). The smallest pupil size (maximum pupil restriction) was used as the primary outcome measure.
Measured: 1-24 hours after drop application
Secondary outcomes (1)
Accommodative Amplitude
Subjective accommodative response was measured via the pull-away AA method.
Measured: 1-24 hours after drop application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start16 Mar 2022
- Primary completion9 Oct 2022
- Study completion9 Oct 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.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants could elect to participate in one or more of our study questions.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah E Singh, OD, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674966
- Sponsor's protocol ID
- 2021-09-14611
- Status last verified
- Mar 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD variables, including data dictionaries, will be available to other researchers upon request to the principal investigator and completion of a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Topical Ophthalmic Low-Dose Atropine on Pupil Size and Accommodation
- ClinicalTrials.gov ID
- NCT07674966
- Acronym / sponsor ID
- 2021-09-14611
- Conditions
- Myopia
- Keywords
- myopia, atropine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 9 Oct 2022 (actual)
- Study completion
- 9 Oct 2022 (actual)
- First posted
- 30 Jun 2026 (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 goal of this clinical study is to learn about the short-term physiological effects of low-dose atropine in healthy volunteers. The study seeks to examine three questions related to low-dose topically applied ophthalmic atropine:
- Does applying two drops of 0.01% atropine sulfate solution cause the same clinical effects as one drop of 0.02% atropine?
- How quickly do the pupil responses and accommodative amplitudes recover following a dose of 0.01% atropine, 0.02% atropine, and 0.05% atropine?
- Does applying a single drop of 0.02% atropine sulfate solution cause the same clinical effects in participants with light vs. dark iris colors? Participants will have their pupil size and accommodative status measured at appropriate intervals to answer the questions above.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants could elect to participate in one or more of our study questions.
| Arm | Type | Receives |
|---|---|---|
| Single drop of 0.02% atropine sulfate solution | Experimental | Drug: Atropine 0.02% Ophthalmic SolutionParticipants received one drop of 0.02% atropine sulfate solution in one eye. |
| Two drops of 0.01% atropine sulfate solution | Experimental | Drug: Atropine 0.01% Ophthalmic SolutionParticipants received two drops of 0.01% atropine sulfate solution in one eye, spaced five minutes apart. |
| observation of pupil responses | Other | Drug: Atropine 0.01% Ophthalmic Solution, Drug: Atropine 0.02% Ophthalmic Solution, Drug: Atropine 0.05% Ophthalmic SolutionSubjects will be observed until pupils fully recover from a single dose of one of the atropine concentrations used. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects may be male or female, of any race, and between 18-40 years old at the time of screening.
- Patients must have best spectacle corrected visual acuity of at least 0.10 logMAR (20/25) in each eye.
- Subjects must be willing and able to apply eye drops to their non-dominant eye and to return for all scheduled follow-up visits.
Key exclusion criteria (5 listed)
- Subjects with any contraindication to atropine use (as listed on package insert). At the time of this submission, the only contraindication listed is: "Hypersensitivity or allergic reaction to any ingredient in formulation"
- Subjects using monamine oxidase inhibitors (MAOIs). These are: Isocarboxazid (Marplan), Phenelzine (Nardil), Selegiline (Emsam), and Tranylcypromine (Parnate).
- Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
- Subjects with a history of intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization >1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring). This includes any patient with open-angle glaucoma, regardless of medication regimen or control. Additionally, any patient with an intra-ocular pressure (IOP) greater than 21 mm Hg at baseline is specifically excluded from eligibility. Subjects with narrow angles (less than Van Herick angle of 3) will also be excluded.
- Subjects who are pregnant, planning to become pregnant or breastfeeding during the course of the study.
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 |
|---|---|---|
| Atropine 0.01% Ophthalmic SolutionTwo drops of 0.01% atropine sulfate solution | Drug | Two drops of 0.01% atropine sulfate solution, observation of pupil responses |
| Atropine 0.02% Ophthalmic SolutionOne drop of 0.02% atropine sulfate solution | Drug | Single drop of 0.02% atropine sulfate solution, observation of pupil responses |
| Atropine 0.05% Ophthalmic SolutionAtropine 0.05% Ophthalmic Solution | Drug | observation of pupil responses |
Primary outcome
Minimum pupil size
Time frame: 1-24 hours after drop application
Dynamic pupil responses to a single pulse of light were measured 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours after instilling the drop(s). The smallest pupil size (maximum pupil restriction) was used as the primary outcome measure.
1 secondary outcome
Accommodative Amplitude
Time frame: 1-24 hours after drop application
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 30 Jun 2026.
- Individual participant dataSharing planned: Yes. All IPD variables, including data dictionaries, will be available to other researchers upon request to the principal investigator and completion of a signed data sharing agreement.
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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.
Sarah E Singh, OD, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atropine 0.01% Ophthalmic Solution, Atropine 0.02% Ophthalmic Solution and Atropine 0.05% Ophthalmic Solution in people with Myopia, run by University of California, Berkeley 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 3 inclusion and 5 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 30 Jun 2026. 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?
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.
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?
Minimum pupil size (time frame: 1-24 hours after drop application). 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 30 Jun 2026.