A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children

NCT06151587 | Recruiting Phase 3

• 1 other identifier: QLM3004-301
• Study Type: interventional
• Target: 735
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and Safety Study of QLM3004 in Myopic Children

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96.

  Effectiveness Evaluation

  96 week

Study Arms (4)

QLM3004 Concentration 1

EXPERIMENTAL

Solution low dose

Drug: QLM3004 Concentration 1

QLM3004 Concentration 2

EXPERIMENTAL

Solution medium dose

Drug: QLM3004 Concentration 2

QLM3004 Concentration 3

EXPERIMENTAL

Solution high dose

Drug: QLM3004 Concentration 3

Placebo

PLACEBO COMPARATOR

Placebo Ophthalmic Solution

Other: Placebo

Interventions

QLM3004 Concentration 1 DRUG

Low dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime

QLM3004 Concentration 1

QLM3004 Concentration 2 DRUG

Medium dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime

QLM3004 Concentration 2

QLM3004 Concentration 3 DRUG

High dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime

QLM3004 Concentration 3

Placebo OTHER

Vehicle

Also known as: Control

Placebo

Eligibility Criteria

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

You may qualify if:

• Age 6 to 12 years
• Myopia -1.00D to -4.00D spherical equivalent (SE) in both eyes as measured by cycloplegic autorefraction.
• Astigmatism ≤1.50 D in both eyes.
• Anisometropia ≤1.50 D SE.
• Informed consent signed by the subjects and/or their legal representatives

You may not qualify if:

• Suffering from serious systemic diseases
• Any eye disease that affect vision or refractive error
• Current or prior history of manifest strabismus, amblyopia, or other ocular pathologic changes
• Acute inflammatory disease or active infection of the eye in either eye, or a history of chronic ocular inflammation or recurrent episodes of ocular inflammation
• Best corrected distance visual acuity in both eyes\<4.9
• Abnormal intra-ocular pressure (\>21 mmHg or difference between two eyes \>5mmHg)
• Current or previous form of myopia control, including but not limited to drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc.
• Systemic or topical use of medications within 3 months that interfere with efficacy evaluation (excluding optometry)
• Allergy or hypersensitivity to atropine, excipients, cyclopentolate or fluorescein sodium
• Participants for whom the clinical significance of ophthalmologic examination abnormalities indicate that one or both eyes are not suitable candidates for treatment based upon the Investigator's medical judgment
• Participation of the drug clinical trial within three month and the device clinical trial within one month
• Anticipated long-term use of ocular or systemic oral corticosteroids during the study period
• Any other condition not suitable for the study per investigator's judgement

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Affiliated Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Zhenjiang Wang

CONTACT

0531-55821369; zhenjiang.wang@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 30, 2023
• Study Start: August 20, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)