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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151587
• Other study ID #: QLM3004-301
• Status: Recruiting
• Phase: Phase 3
• Start date: August 20, 2023
• Est. completion date: June 2027

Study information

• Verified date: November 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Zhenjiang Wang
• Phone: 0531-55821369
• Email: zhenjiang.wang[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficacy and Safety Study of QLM3004 in Myopic Children

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 735
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• QLM3004 Concentration 1
Low dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
• QLM3004 Concentration 2
Medium dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
• QLM3004 Concentration 3
High dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime

Other:
• Placebo
Vehicle

Locations

Country	Name	City	State
China	The Affiliated Eye Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96.	Effectiveness Evaluation	96 week