Slowing the Progression of Myopia in ChildrenPhase 2/3NCT07844356
The Safety and Efficacy of HR19034 in Children With Myopia
A Phase 2/3 study testing HR19034 in people with Slowing the Progression of Myopia in Children, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of HR19034 Eye Drops. To explore the reasonable dosage of HR19034 for slowing the progression of myopia in children Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Slowing the Progression of Myopia in Children
- What is being tested?
- HR19034
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 509 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2021to 25 Jul 2025
- Phase
- Phase 2/3
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female participants aged ≥6 and <12 years at the time of informed consent.
- Refractive status meets the following conditions:
- Myopia of 0.5 D (diopters) to 4.00 D (inclusive) in both eyes; B) Astigmatism ≤1.50 D in both eyes; c) Anisometropia ≤1.5 D;
- Intraocular pressure ≤21 mmHg;
- The best corrected distance visual acuity of both eyes of logMAR 0 or better;
Who cannot join
- Allergy to the investigational drug or any of its components.
- Any abnormality of the refractive system in either eye, including but not limited to keratoconus, lenticonus, or spherophakia.
- Systemic conditions that may affect refractive development or predispose to high myopia, such as Down syndrome, Marfan syndrome, retinopathy of prematurity, or neonatal hypoxic-ischemic encephalopathy.
- Any other ocular abnormality or disease affecting vision in either eye, including ptosis, congenital corneal abnormalities, corneal leukoma, congenital lens abnormalities, cataract, macular lesions, choroidal lesions, severe vitreous opacity, or retinal lesions.
- History of glaucoma and/or shallow anterior chamber in either eye.
- History or current presence of significant strabismus, amblyopia, or nystagmus.
Show all 13Show fewer
- Prior eyelid surgery, strabismus surgery, intraocular surgery, or refractive surgery.
- Systemic or local use of medications that may affect efficacy evaluation within 3 months prior to screening, including anticholinergics (e.g., atropine, pirenzepine), cholinergics (e.g., pilocarpine), or drugs affecting pupil size or accommodation (e.g., Belladonna tablets, morphine, sedative-hypnotics). Exception: non-atropine mydriatics used solely for dilated eye examinations, provided they are not continuous, regular, or long-term use.
- Use of myopia control treatments within 1 month prior to screening, including atropine or other antimuscarinic agents, bifocal/progressive/multifocal contact lenses or spectacles, orthokeratology lenses, or rigid gas permeable contact lenses for myopia reduction.
- History or current presence of systemic diseases, including immune system disorders, central nervous system disorders, asthma, diabetes, severe cardiopulmonary dysfunction, or severe hepatic or renal dysfunction.
- Clear family history of high myopia.
- Participation in another interventional clinical trial within 3 months prior to randomization.
- Any other condition that, in the opinion of the investigator, would make the subject unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Xiamen Eye Center, Affiliated to Xiamen University
Xiamen, Fujian, 361016
About this study
Official title: Evaluate the Efficacy and Safety of HR19034 Eye Drops for Slowing the Progression of Myopia in Children: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Phase II/III Clinical Trial
The study is being conducted to evaluate the efficacy, and safety of HR19034 Eye Drops. To explore the reasonable dosage of HR19034 for slowing the progression of myopia in children
- Being tested
- HR19034, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR19034Drug
HR19034 Dose 1
HR19034Drug
HR19034 Dose 2
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HR19034 Dose 1 | Experimental | Not described Receives: Drug: HR19034 |
| Treatment group B: HR19034 Dose 2 | Experimental | Not described Receives: Drug: HR19034 |
| Treatment group C: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in spherical equivalent refraction (SER) measured by cycloplegic autorefraction in the study eye
Measured: Baseline to Week 96
Secondary outcomes (13)
Change from baseline in spherical equivalent refraction (SER) in the fellow eye
Measured: Baseline to Week 96
Change from baseline in axial length (AL) in the study eye and fellow eye
Measured: Baseline to Week 96
Percentage of participants with progression in SER of more than 0.75 D in the study eye and fellow eye
Measured: Baseline to Week 96
Percentage of participants with progression in SER of more than 0.50 D in the study eye and fellow eye
Measured: Baseline to Week 96
Percentage of participants with progression in SER of more than 1.00 D in the study eye and fellow eye
Measured: Baseline to Week 96
Change from baseline in vision-related quality of life
Measured: Baseline to Week 96
Change from baseline in SER in the study eye and fellow eye
Measured: Baseline to Week 48
Change from baseline in AL in the study eye and fellow eye
Measured: Baseline to Week 48
Percentage of participants with progression in SER of more than 0.75 D, 0.50 D and 1.00 D in the study eye and fellow eye
Measured: Baseline to Week 48
Change from baseline in vision-related quality of life
Measured: Baseline to Week 48
Change from baseline/Week 96 in SER in the study eye and fellow eye
Measured: Baseline/Week 96 to Week 120 and 144
Change from baseline/Week 96 in AL in the study eye and fellow eye
Measured: Baseline/Week 96 to Week 120 and 144
Percentage of participants with progression in SER from Week 96 of more than 0.75 D in the study eye and fellow eye
Measured: Week 96 to Week 120 and 144]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start14 Oct 2021
- Primary completion9 Aug 2024
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Slowing the Progression of Myopia in ChildrenStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HR19034 compared with placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844356
- Sponsor's protocol ID
- HR19034-301
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy and Safety of HR19034 Eye Drops for Slowing the Progression of Myopia in Children: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Phase II/III Clinical Trial
- ClinicalTrials.gov ID
- NCT07844356
- Acronym / sponsor ID
- HR19034-301
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 28 Sep 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 study is being conducted to evaluate the efficacy, and safety of HR19034 Eye Drops. To explore the reasonable dosage of HR19034 for slowing the progression of myopia in children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- HR19034 compared with placebo.
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HR19034 Dose 1 | Experimental | Drug: HR19034 |
| Treatment group B: HR19034 Dose 2 | Experimental | Drug: HR19034 |
| Treatment group C: Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female participants aged ≥6 and <12 years at the time of informed consent.
- Refractive status meets the following conditions:
- Intraocular pressure ≤21 mmHg;
- The best corrected distance visual acuity of both eyes of logMAR 0 or better;
Key exclusion criteria (13 listed)
- Allergy to the investigational drug or any of its components.
- Any abnormality of the refractive system in either eye, including but not limited to keratoconus, lenticonus, or spherophakia.
- Systemic conditions that may affect refractive development or predispose to high myopia, such as Down syndrome, Marfan syndrome, retinopathy of prematurity, or neonatal hypoxic-ischemic encephalopathy.
- Any other ocular abnormality or disease affecting vision in either eye, including ptosis, congenital corneal abnormalities, corneal leukoma, congenital lens abnormalities, cataract, macular lesions, choroidal lesions, severe vitreous opacity, or retinal lesions.
- History of glaucoma and/or shallow anterior chamber in either eye.
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 |
|---|---|---|
| HR19034HR19034 Dose 1 | Drug | Treatment group A: HR19034 Dose 1 |
| HR19034HR19034 Dose 2 | Drug | Treatment group B: HR19034 Dose 2 |
| PlaceboPlacebo | Drug | Treatment group C: Placebo |
Primary outcome
Change from baseline in spherical equivalent refraction (SER) measured by cycloplegic autorefraction in the study eye
Time frame: Baseline to Week 96
13 secondary outcomes
Change from baseline in spherical equivalent refraction (SER) in the fellow eye
Time frame: Baseline to Week 96
Change from baseline in axial length (AL) in the study eye and fellow eye
Time frame: Baseline to Week 96
Percentage of participants with progression in SER of more than 0.75 D in the study eye and fellow eye
Time frame: Baseline to Week 96
Percentage of participants with progression in SER of more than 0.50 D in the study eye and fellow eye
Time frame: Baseline to Week 96
Percentage of participants with progression in SER of more than 1.00 D in the study eye and fellow eye
Time frame: Baseline to Week 96
Change from baseline in vision-related quality of life
Time frame: Baseline to Week 96
Change from baseline in SER in the study eye and fellow eye
Time frame: Baseline to Week 48
Change from baseline in AL in the study eye and fellow eye
Time frame: Baseline to Week 48
Percentage of participants with progression in SER of more than 0.75 D, 0.50 D and 1.00 D in the study eye and fellow eye
Time frame: Baseline to Week 48
Change from baseline in vision-related quality of life
Time frame: Baseline to Week 48
Change from baseline/Week 96 in SER in the study eye and fellow eye
Time frame: Baseline/Week 96 to Week 120 and 144
Change from baseline/Week 96 in AL in the study eye and fellow eye
Time frame: Baseline/Week 96 to Week 120 and 144
Percentage of participants with progression in SER from Week 96 of more than 0.75 D in the study eye and fellow eye
Time frame: Week 96 to Week 120 and 144]
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 28 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HR19034 in people with Slowing the Progression of Myopia in Children, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
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 5 inclusion and 13 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 28 Sep 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 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 from baseline in spherical equivalent refraction (SER) measured by cycloplegic autorefraction in the study eye (time frame: Baseline to Week 96). 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 28 Sep 2026.