MyopiaPhase 3NCT06151587
A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children
A Phase 3 study testing QLM3004 Concentration 1, QLM3004 Concentration 2 and QLM3004 Concentration 3 in people with Myopia, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Efficacy and Safety Study of QLM3004 in Myopic Children Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- QLM3004 Concentration 1, QLM3004 Concentration 2 and QLM3004 Concentration 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 735 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2023to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
jia Qu, M.D., 0577-88068860, jqu@wz.zj.cn
About this study
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
Efficacy and Safety Study of QLM3004 in Myopic Children
Read the 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.
- Conditions
- Myopia
- Being tested
- QLM3004 Concentration 1, QLM3004 Concentration 2, QLM3004 Concentration 3, Placebo
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLM3004 Concentration 1Drug
Low dose of QLM3004 Ophthalmic Solution
1 drop in each eye at bedtime
QLM3004 Concentration 2Drug
Medium dose of QLM3004 Ophthalmic Solution
1 drop in each eye at bedtime
QLM3004 Concentration 3Drug
High dose of QLM3004 Ophthalmic Solution
1 drop in each eye at bedtime
PlaceboOther
Also called Control
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| QLM3004 Concentration 1 | Experimental | Solution low dose Receives: Drug: QLM3004 Concentration 1 |
| QLM3004 Concentration 2 | Experimental | Solution medium dose Receives: Drug: QLM3004 Concentration 2 |
| QLM3004 Concentration 3 | Experimental | Solution high dose Receives: Drug: QLM3004 Concentration 3 |
| Placebo | Placebo comparator | Placebo Ophthalmic Solution Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96.
Effectiveness Evaluation
Measured: 96 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start20 Aug 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 735 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151587
- Sponsor's protocol ID
- QLM3004-301
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06151587
- Acronym / sponsor ID
- QLM3004-301
- Conditions
- Myopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 735 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QLM3004 Concentration 1 | Experimental | Drug: QLM3004 Concentration 1Solution low dose |
| QLM3004 Concentration 2 | Experimental | Drug: QLM3004 Concentration 2Solution medium dose |
| QLM3004 Concentration 3 | Experimental | Drug: QLM3004 Concentration 3Solution high dose |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Ophthalmic Solution |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLM3004 Concentration 1Low dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime | Drug | QLM3004 Concentration 1 |
| QLM3004 Concentration 2Medium dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime | Drug | QLM3004 Concentration 2 |
| QLM3004 Concentration 3High dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime | Drug | QLM3004 Concentration 3 |
| PlaceboAlso: ControlVehicle | Other | Placebo |
Primary outcome
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96.
Time frame: 96 week
Effectiveness Evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QLM3004 Concentration 1, QLM3004 Concentration 2 and QLM3004 Concentration 3 in people with Myopia, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenjiang Wang (0531-55821369, zhenjiang.wang@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96. (time frame: 96 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.