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

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Different Concentrations of QLM3004 in Delaying the Progression of Myopia in Children

Efficacy and Safety Study of QLM3004 in Myopic Children

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Other: Placebo; Drug: QLM3004 Concentration 1; Drug: QLM3004 Concentration 2; Drug: QLM3004 Concentration 3

Detailed Description

The study was divided into 2 phases, with Stage 1 being the primary efficacy and safety confirmation phase and Stage 2 a post-withdrawal observation period.

Stage 1:To evaluate the safety and efficacy of 3 concentrations of QLM3004 compared to Vehicle (placebo)for slowing the progression of myopia in children over a 96-week treatment period.

Stage 2:subjects will enter Period 2 of the study, and Period 2 will be a post-withdrawal observation period, which will not serve as a validation basis for the efficacy and safety of QLM3004.

• Study Type: Interventional
• Enrollment (Estimated): 735
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhenjiang Wang; Phone Number: 0531-55821369; Email: zhenjiang.wang@qilu-pharma.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The Affiliated Eye Hospital of Wenzhou Medical University
      • Contact: jia Qu, M.D.; Phone Number: 0577-88068860; Email: jqu@wz.zj.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo Ophthalmic Solution	Other: Placebo; Vehicle; Other Names: Control
Experimental: QLM3004 Concentration 1; Solution low dose	Drug: QLM3004 Concentration 1; Low dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
Experimental: QLM3004 Concentration 2; Solution medium dose	Drug: QLM3004 Concentration 2; Medium dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
Experimental: QLM3004 Concentration 3; Solution high dose	Drug: QLM3004 Concentration 3; High dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96.	Effectiveness Evaluation	96 week

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: QLM3004-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No