MyopiaPhase 3NCT02870478
The Effects of Low Concentration Atropine on Pupil Size and Accommodation
A Phase 3 study testing Atropine in people with Myopia, run by University of California, Berkeley at 1 site in United States.
Trial summary
The purpose of this study is to determine whether less frequent dosing of atropine drops may be as effective as daily dosing for the treatment of progressive myopia. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 20 Nov 2019
- Phase
- Phase 3
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must have vision that is correctable to 20/20 in each eye
- Participants must also have normal binocular vision (no history of manifest eye turns or eye surgeries to correct an eye turn)
- Participants must have normal accommodation (amplitude and facility within a normal range based on the subject's age)
- Participants must have normal ocular health
Who cannot join
- Previous chronic use of atropine
- Participants who are pregnant, plan to become pregnant, or are breastfeeding
- Sensitivity or allergy to atropine
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Berkeley, Department of Vision Science
Berkeley, California, 94720-2020
About this study
Official title: A Study of Time and Dose-dependent Effect of Low Concentration Atropine on Accommodation and Pupil Size
The purpose of this study is to determine whether less frequent dosing of atropine drops may be as effective as daily dosing for the treatment of progressive myopia.
Read the detailed description
Myopia has become an epidemic in developed countries, particularly in Asian countries and in the United States. Myopia, or near-sightedness, is a result of uncontrolled axial elongation of the eye. Besides needing optical correction in order to see clearly, myopia can result in many sight-threatening complications, such as retinal thinning, retinal holes and tears, retinal detachment, and vascular proliferation. Atropine drops have been used in clinical practice for over 100 years at varying concentrations and different dosing regimens. The proposed small study seeks to establish evidence-based treatment (dosing) guidelines for the use of low dose atropine for myopia control.
The specific objectives of this study are:
- To assess the effects of 0.01% atropine on pupil dilation and accommodation as a measure of active drug levels in the eye when dosed twice per week compared to daily
- To assess the subjective effects of 0.01% atropine on the subjects' vision
The study will involve one 60-minute screening session, twenty 15-minute testing sessions, and one 8-hour testing session, for a total of 14 hours over five to six weeks. Following the screening exam (information will be collected on the screening form), the subject will be randomly assigned to treat their non-dominant eye with:
- 0.01% daily dosing for two weeks followed by a 1-week washout then 0.01% twice per week for two weeks
- 0.01% twice per week dosing for two weeks, followed by a 1-week washout, then 0.01% daily for two weeks.
Test sessions (expected to be no more than 15 mins in length) will be held daily during the testing period and scheduled at the subject's convenience. Session measurements will include best-corrected visual acuity, subjective amplitude of accommodation, objective amplitude of accommodation, and pupil size, as described previously (see screening section 7b). An anterior segment slit lamp biomicroscopy exam will also be performed to ensure good ocular health. The subject will also be asked to fill out a brief symptom questionnaire (attached) while they are present for the test session. Information will be recorded on the data collection sheet for this portion of the testing.
Additionally, measurements of pupil size and accommodation will be taken prior to the instillation of a single dose of 0.01% atropine, and then at 1min, 5 min, 30 min, 1hr, 2hr, 4hr, and 8hr post-instillation.
- Conditions
- Myopia
- Being tested
- Atropine
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
Also called atropine sulfate ophthalmic solution
Dosing frequency comparison, using atropine sulfate 1% solution diluted to 0.01% and 0.05% by Leiter's Compounding Pharmacy
| Study group | Role | What they receive |
|---|---|---|
| 0.01% atropine daily | Active comparator | Nightly dosing of 0.01% atropine Receives: Drug: Atropine |
| 0.01% atropine twice per week | Experimental | Atropine dosed twice per week Receives: Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pupil size at 1 week
Measured: Measured at baseline and again 1 week after first using drop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Liu, OD, MPH, PhD, Principal investigator, UC Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870478
- Sponsor's protocol ID
- IND 128961
- Status last verified
- Nov 2020
- First submitted
- 27 Jul 2016
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Time and Dose-dependent Effect of Low Concentration Atropine on Accommodation and Pupil Size
- ClinicalTrials.gov ID
- NCT02870478
- Acronym / sponsor ID
- IND 128961
- Conditions
- Myopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 17 Aug 2016 (estimated)
- 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 determine whether less frequent dosing of atropine drops may be as effective as daily dosing for the treatment of progressive myopia.
Detailed description
Myopia has become an epidemic in developed countries, particularly in Asian countries and in the United States. Myopia, or near-sightedness, is a result of uncontrolled axial elongation of the eye. Besides needing optical correction in order to see clearly, myopia can result in many sight-threatening complications, such as retinal thinning, retinal holes and tears, retinal detachment, and vascular proliferation. Atropine drops have been used in clinical practice for over 100 years at varying concentrations and different dosing regimens. The proposed small study seeks to establish evidence-based treatment (dosing) guidelines for the use of low dose atropine for myopia control.
The specific objectives of this study are:
- To assess the effects of 0.01% atropine on pupil dilation and accommodation as a measure of active drug levels in the eye when dosed twice per week compared to daily
- To assess the subjective effects of 0.01% atropine on the subjects' vision
The study will involve one 60-minute screening session, twenty 15-minute testing sessions, and one 8-hour testing session, for a total of 14 hours over five to six weeks. Following the screening exam (information will be collected on the screening form), the subject will be randomly assigned to treat their non-dominant eye with:
- 0.01% daily dosing for two weeks followed by a 1-week washout then 0.01% twice per week for two weeks
- 0.01% twice per week dosing for two weeks, followed by a 1-week washout, then 0.01% daily for two weeks.
Test sessions (expected to be no more than 15 mins in length) will be held daily during the testing period and scheduled at the subject's convenience. Session measurements will include best-corrected visual acuity, subjective amplitude of accommodation, objective amplitude of accommodation, and pupil size, as described previously (see screening section 7b). An anterior segment slit lamp biomicroscopy exam will also be performed to ensure good ocular health. The subject will also be asked to fill out a brief symptom questionnaire (attached) while they are present for the test session. Information will be recorded on the data collection sheet for this portion of the testing.
Additionally, measurements of pupil size and accommodation will be taken prior to the instillation of a single dose of 0.01% atropine, and then at 1min, 5 min, 30 min, 1hr, 2hr, 4hr, and 8hr post-instillation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.01% atropine daily | Active comparator | Drug: AtropineNightly dosing of 0.01% atropine |
| 0.01% atropine twice per week | Experimental | Drug: AtropineAtropine dosed twice per week |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must have vision that is correctable to 20/20 in each eye
- Participants must also have normal binocular vision (no history of manifest eye turns or eye surgeries to correct an eye turn)
- Participants must have normal accommodation (amplitude and facility within a normal range based on the subject's age)
- Participants must have normal ocular health
Key exclusion criteria (3 listed)
- Previous chronic use of atropine
- Participants who are pregnant, plan to become pregnant, or are breastfeeding
- Sensitivity or allergy to atropine
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 |
|---|---|---|
| AtropineAlso: atropine sulfate ophthalmic solutionDosing frequency comparison, using atropine sulfate 1% solution diluted to 0.01% and 0.05% by Leiter's Compounding Pharmacy | Drug | 0.01% atropine daily, 0.01% atropine twice per week |
Primary outcome
Change in pupil size at 1 week
Time frame: Measured at baseline and again 1 week after first using drop
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 4 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Maria Liu, OD, MPH, PhD principal investigator
UC Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atropine 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 4 inclusion and 3 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 4 Nov 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in pupil size at 1 week (time frame: Measured at baseline and again 1 week after first using drop). 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 4 Nov 2020.