A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in... | NCT06151587

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

NCT06151587

Sponsor

Qilu Pharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Nov 30, 2023Actual

Enrollment

735Estimated

Phase

Phase 3

Conditions

Myopia

Interventions

QLM3004 Concentration 1
QLM3004 Concentration 2
QLM3004 Concentration 3
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2023Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Nov 20, 2023

First Submission Date that Met QC Criteria

Nov 21, 2023

First Posted Date

Nov 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2023

Last Update Posted Date

Nov 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Efficacy and Safety Study of QLM3004 in Myopic Children

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

735Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
QLM3004 Concentration 1	Drug	Low dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime	QLM3004 Concentration 1

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases