MyopiaPhase 3Mini-CHAMPNCT06209281

A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops

A Phase 3 study testing Lower dose atropine sulfate eye drops and Low dose atropine sulfate eye drops in people with Myopia, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

This study was a randomized, double-blind, placebo-controlled, multicenter, superiority design, phase III clinical trial to compare the efficacy and safety of two low-concentration atropine sulfate eye drops versus placebo in delaying myopia progression in children. Read more about this study

Who is it for?: Ages 6 to 10 years
Conditions the study is for: Myopia
What is being tested?: Lower dose atropine sulfate eye drops and Low dose atropine sulfate eye drops
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 526 participants
Where: 1 siteChina
Study dates: 13 May 2022to Dec 2025
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 6 to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

Child (female or male) aged 6 to 10 years.
Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measured by cycloplegic autorefraction.
If present, astigmatism of ≤1.50 D in each eye as measured by cycloplegic autorefraction.
Anisometropia SER of < 1.50 D as measured by cycloplegic autorefraction.

Who cannot join

History of any disease or syndrome that predisposed the subject to severe myopia (e.g.,Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus,spherophakia).
Chronic use of any topical or systemic antimuscarinic/anticholinergic medications (e.g.,atropine, scopolamine, tropicamide) within 21 days prior to screening and/or anticipated need for chronic use during the study period (i.e., more than 7 consecutive days in 1 month or more than 30 total days in 1 year).
Use of cycloplegic drops for dilated ocular exam was allowable.
Heart rate persistently (for more than 10 minutes) > 120 beats per minute.
Allergy to study drugs.

Trial locations and contacts

1 site in 1 country.

China1 site

Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops in Slowing the Progression of Myopia in Children

Read the detailed description

Eligible subjects were screened and randomly assigned to the placebo control group, the lower dose group, and the lower dose group. Subjects received the study drug in both eyes, 1 drop each time, once every night before sleep, for continuous administration.A total of 526 subjects were planned to be enrolled。

Statistical analyses were performed with the use of SAS software, version 9.4, without any specific description. All statistical tests were two-sided at a 0.05 level.

Conditions: Myopia
Being tested: Lower dose atropine sulfate eye drops, Low dose atropine sulfate eye drops, placebo
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lower dose atropine sulfate eye dropsDrug
Also called Eye drops
Administer to eyes
Low dose atropine sulfate eye dropsDrug
Also called Eye drops
Administer to eyes
placeboDrug
Also called Eye drops
Administer to eyes

Study groups in NCT06209281
Study group	Role	What they receive
Experimental group 1	Experimental	1 drop each time, once every night at bedtime Receives: Drug: Lower dose atropine sulfate eye drops; Drug: Low dose atropine sulfate eye drops
Experimental group 2	Experimental	1 drop each time, once every night at bedtime Receives: Drug: Low dose atropine sulfate eye drops
control group	Experimental	1 drop each time, once every night at bedtime Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cycloplegic Autorefraction(low)
Group difference in the proportion of subjects eyes with myopia progression (SER) less than -0.50 D at M12 visit with low atropine versus placebo.
Measured: twelve months

Secondary outcomes (2)

Cycloplegic Autorefraction(lower)
Group difference in the proportion of subjects eyes with myopia progression (SER) less than -0.50 D at M12 visit with lower atropine versus placebo.
Measured: twelve months
Cycloplegic Autorefraction(SER)
Between-group difference in the mean change from baseline in SER at visit M12
Measured: twelve months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 2022Dec 2025

First posted17 Jan 2024
Study start13 May 2022
Primary completion20 Aug 2023
Study completionDec 2025 (estimated)

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 526 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06209281
Sponsor's protocol ID: ZKO-ATP-202105-Mini-CHAMP
Acronym: Mini-CHAMP
Status last verified: Jul 2025
First submitted: 5 Jan 2024
Last updated: 30 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops in Slowing the Progression of Myopia in Children
ClinicalTrials.gov ID: NCT06209281
Acronym / sponsor ID: Mini-CHAMP / ZKO-ATP-202105-Mini-CHAMP
Conditions: Myopia
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 526 participants (actual)
Lead sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.Industry (pharma, biotech, devices)
Study start: 13 May 2022 (actual)
Primary completion: 20 Aug 2023 (actual)
Study completion: Dec 2025 (estimated)
First posted: 17 Jan 2024 (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.

Detailed description

Statistical analyses were performed with the use of SAS software, version 9.4, without any specific description. All statistical tests were two-sided at a 0.05 level.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Experimental group 1	Experimental	Drug: Lower dose atropine sulfate eye drops, Drug: Low dose atropine sulfate eye drops1 drop each time, once every night at bedtime
Experimental group 2	Experimental	Drug: Low dose atropine sulfate eye drops1 drop each time, once every night at bedtime
control group	Experimental	Drug: placebo1 drop each time, once every night at bedtime

Who may qualify

Ages: 6 to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Child (female or male) aged 6 to 10 years.
Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measured by cycloplegic autorefraction.
If present, astigmatism of ≤1.50 D in each eye as measured by cycloplegic autorefraction.
Anisometropia SER of < 1.50 D as measured by cycloplegic autorefraction.

Key exclusion criteria (6 listed)

History of any disease or syndrome that predisposed the subject to severe myopia (e.g.,Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus,spherophakia).
Chronic use of any topical or systemic antimuscarinic/anticholinergic medications (e.g.,atropine, scopolamine, tropicamide) within 21 days prior to screening and/or anticipated need for chronic use during the study period (i.e., more than 7 consecutive days in 1 month or more than 30 total days in 1 year).
Use of cycloplegic drops for dilated ocular exam was allowable.
Heart rate persistently (for more than 10 minutes) > 120 beats per minute.

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
Lower dose atropine sulfate eye dropsAlso: Eye dropsAdminister to eyes	Drug	Experimental group 1
Low dose atropine sulfate eye dropsAlso: Eye dropsAdminister to eyes	Drug	Experimental group 1, Experimental group 2
placeboAlso: Eye dropsAdminister to eyes	Drug	control group

Primary outcome

Cycloplegic Autorefraction(low)
Time frame: twelve months
Group difference in the proportion of subjects eyes with myopia progression (SER) less than -0.50 D at M12 visit with low atropine versus placebo.

2 secondary outcomes

Cycloplegic Autorefraction(lower)
Time frame: twelve months
Cycloplegic Autorefraction(SER)
Time frame: twelve months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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.

Xiaomei Qu principal investigator

Eye & ENT Hospital of Fudan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2025. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

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?

Cycloplegic Autorefraction(low) (time frame: twelve months). 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 NCT06209281.

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 Jul 2025.