Myopia, ProgressiveLAMCNCT05597163
Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents
A study testing low concentration atropine (0.01%), low concentration atropine (0.025%) and low concentration atropine (0.05%) in people with Myopia, Progressive, run by Shanghai Eye Disease Prevention and Treatment Center.
Trial summary
To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- low concentration atropine (0.01%), low concentration atropine (0.025%) and low concentration atropine (0.05%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 588 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to 1 Nov 2025
- Phase
- Interventional
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The age of the screening stage is 3-15 years, both sexes;
- One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8;
- Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;
- Informed consent from the guardian and the child.
Who cannot join
- strabismus, amblyopia or other ocular abnormalities;
- The presence of systemic disease abnormalities;
- have taken myopia control treatment in the past month;
- Allergic to low concentration atropine or sulfuric acid drugs.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Double-blind, Randomized, Controlled Clinical Study of the Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents
To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.
- Conditions
- Myopia, Progressive
- Being tested
- low concentration atropine (0.01%), low concentration atropine (0.025%), low concentration atropine (0.05%), Placebo
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low concentration atropine (0.01%)Drug
0.01% atropine eye drop
low concentration atropine (0.025%)Drug
0.025% atropine eye drop
low concentration atropine (0.05%)Drug
0.05% atropine eye drop
PlaceboDrug
Placebo eye drop
| Study group | Role | What they receive |
|---|---|---|
| 0.01% atropine | Experimental | 0.01% atropine eye drop Receives: Drug: low concentration atropine (0.01%) |
| 0.025% atropine | Experimental | 0.025% atropine eye drop Receives: Drug: low concentration atropine (0.025%) |
| 0.05% atropine | Experimental | 0.05% atropine eye drop Receives: Drug: low concentration atropine (0.05%) |
| cross-over | Other | first year: placebo second year: 0.05% atropine eye drop Receives: Drug: low concentration atropine (0.05%); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of SE changes over -0.75D
Measured: 2 years
Secondary outcomes (1)
AL change
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start15 Jan 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ProgressiveStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Peking University People's Hospital, Shandong University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Haidong Zou, Study director, Shanghai Eye Disease Prevention and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597163
- Sponsor's protocol ID
- kjb-atp-v1.1-20220825
- Acronym
- LAMC
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Controlled Clinical Study of the Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents
- ClinicalTrials.gov ID
- NCT05597163
- Acronym / sponsor ID
- LAMC / kjb-atp-v1.1-20220825
- Conditions
- Myopia, Progressive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Peking University People's Hospital, Shandong University of Traditional Chinese Medicine
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 27 Oct 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.
To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.01% atropine | Experimental | Drug: low concentration atropine (0.01%)0.01% atropine eye drop |
| 0.025% atropine | Experimental | Drug: low concentration atropine (0.025%)0.025% atropine eye drop |
| 0.05% atropine | Experimental | Drug: low concentration atropine (0.05%)0.05% atropine eye drop |
| cross-over | Other | Drug: low concentration atropine (0.05%), Drug: Placebofirst year: placebo second year: 0.05% atropine eye drop |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The age of the screening stage is 3-15 years, both sexes;
- One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8;
- Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;
- Informed consent from the guardian and the child.
Key exclusion criteria (4 listed)
- strabismus, amblyopia or other ocular abnormalities;
- The presence of systemic disease abnormalities;
- have taken myopia control treatment in the past month;
- Allergic to low concentration atropine or sulfuric acid drugs.
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 |
|---|---|---|
| low concentration atropine (0.01%)0.01% atropine eye drop | Drug | 0.01% atropine |
| low concentration atropine (0.025%)0.025% atropine eye drop | Drug | 0.025% atropine |
| low concentration atropine (0.05%)0.05% atropine eye drop | Drug | 0.05% atropine, cross-over |
| PlaceboPlacebo eye drop | Drug | cross-over |
Primary outcome
Proportion of SE changes over -0.75D
Time frame: 2 years
1 secondary outcome
AL change
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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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.
Haidong Zou study director
Shanghai Eye Disease Prevention and Treatment Center
Questions about this trial
What is this clinical trial studying?
A study testing low concentration atropine (0.01%), low concentration atropine (0.025%) and low concentration atropine (0.05%) in people with Myopia, Progressive, run by Shanghai Eye Disease Prevention and Treatment Center.
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 4 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: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haidong Zou (+86021-53555032, dllcrco@shsyf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of SE changes over -0.75D (time frame: 2 years). 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 11 Jan 2023.