The Safety and Efficacy of HR19034 in Children With Myopia

NCT07844356 | Completed Phase 2

• 1 other identifier: HR19034-301
• Study Type: interventional
• Target: 509
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Slowing the Progression of Myopia in Children

Outcome Measures

Primary Outcomes (1)

• Change from baseline in spherical equivalent refraction (SER) measured by cycloplegic autorefraction in the study eye

  Baseline to Week 96

Secondary Outcomes (13)

• Change from baseline in spherical equivalent refraction (SER) in the fellow eye

  Baseline to Week 96

• Change from baseline in axial length (AL) in the study eye and fellow eye

  Baseline to Week 96

• Percentage of participants with progression in SER of more than 0.75 D in the study eye and fellow eye

  Baseline to Week 96

• Percentage of participants with progression in SER of more than 0.50 D in the study eye and fellow eye

  Baseline to Week 96

• Percentage of participants with progression in SER of more than 1.00 D in the study eye and fellow eye

  Baseline to Week 96

Study Arms (3)

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

Interventions

Placebo DRUG

Placebo

Treatment group C: Placebo

HR19034 DRUG

HR19034 Dose 1

Treatment group A: HR19034 Dose 1

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female participants aged ≥6 and \<12 years at the time of informed consent.
• Refractive status meets the following conditions:
• a) 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chengdu Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Xiamen Eye Center, Affiliated to Xiamen University

Xiamen, Fujian, 361016, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HR19034 compared with placebo.

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start: October 14, 2021
• Primary Completion: August 9, 2024
• Study Completion: July 25, 2025
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

CN (1)