MyopiaNCT06850168
Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
A study testing SVL, SVL with passive red-light emission and MCL in people with Myopia, run by Essilor International at 1 site in Singapore.
Trial summary
The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Myopia
- What is being tested?
- SVL, SVL with passive red-light emission and MCL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSingapore
- Study dates
- 26 Jun 2025to Dec 2027
- Phase
- Interventional
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.
- Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.
- Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.
- Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen).
- Be in good general health, based on his/her and parent's/guardian's knowledge.
- Agree to wear spectacles for >12 hours/day and at least 6 days/week.
- Willingness and ability to participate in investigation for 2 years and attend scheduled visits.
Who cannot join
- Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.)
- Any binocular vision anomalies
- Amblyopia
- Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month.
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- Participation in any clinical investigation within 30 days of the baseline visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Boudenne contact
Singapore1 site, 1 recruiting
- Recruiting
Essilor R&D Centre Singapore
Singapore
Celine Carimalo, 67134617, carimalc@essilor.com.sg
About this study
The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:
Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children?
Read more
Researchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression.
Participants will:
- Wear the study spectacles
- Visit Essilor R\&D Centre for follow-up sessions
- Conditions
- Myopia
- Being tested
- SVL, SVL with passive red-light emission, MCL, MCL with passive red-light emission
- Keywords
- Refractive error, Eye disease, Axial length, Myopia control
- Medical subject headings
- Myopia, Refractive Errors, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVLDevice
Dispensed to one eye in Year 1
SVL with passive red-light emissionDevice
Dispensed to the contralateral eye in Year 1.
MCLDevice
Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).
MCL with passive red-light emissionDevice
Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | (Year 1) OD: SVL with passive red-light emission; OS: SVL (Year 2) OD: MCL; OS: MCL with passive red-light emission Receives: Device: SVL; Device: SVL with passive red-light emission; Device: MCL; Device: MCL with passive red-light emission |
| Group B | Experimental | (Year 1) OD: SVL; OS: SVL with passive red-light emission (Year 2) OD: MCL with passive red-light emission; OS: MCL Receives: Device: SVL; Device: SVL with passive red-light emission; Device: MCL; Device: MCL with passive red-light emission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Axial Length
Measured: From baseline to 12 months
Change in Axial Length
Measured: From 12 months to 24 months
Secondary outcomes (2)
Change in Spherical Equivalent Refraction
Measured: From baseline to 12 months
Change in Spherical Equivalent Refraction
Measured: From 12 months to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start26 Jun 2025
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Essilor InternationalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 2-year, randomized, double-masked, contralateral, exploratory clinical trial with the objective to evaluate the efficacy of two test lenses designed with passive red-light emission in the control of myopia progression. The subject starts by wearing standard SVL, designed with passive red-light emission in one eye, and standard SVL in the contralateral eye. After 1 year, the eye wearing SVL designed with passive red-light emission will be replaced with standard MCL, and the contralateral eye will be replaced with standard MCL designed with passive red-light emission. At the end of the 2-year period, each eye would be exposed to lenses designed with passive red-light emission for 1 year each. There will be a total of 11 study visits with follow-up periods at 6 months, 12 months, 18 months and 24 months.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Tan, Principal investigator, Essilor R&D Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850168
- Sponsor's protocol ID
- WS10367
- Status last verified
- Aug 2025
- First submitted
- 24 Feb 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang Y, Zhu Z, Tan X, Kong X, Zhong H, Zhang J, Xiong R, Yuan Y, Zeng J, Morgan IG, He M. Effect of Repeated Low-Level Red-Light Therapy for Myopia Control in Children: A Multicenter Randomized Controlled Trial. Ophthalmology. 2022 May;129(5):509-519. doi: 10.1016/j.ophtha.2021.11.023. Epub 2021 Dec 1.
PubMed 34863776Dong J, Zhu Z, Xu H, He M. Myopia Control Effect of Repeated Low-Level Red-Light Therapy in Chinese Children: A Randomized, Double-Blind, Controlled Clinical Trial. Ophthalmology. 2023 Feb;130(2):198-204. doi: 10.1016/j.ophtha.2022.08.024. Epub 2022 Aug 29.
PubMed 36049646
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
- ClinicalTrials.gov ID
- NCT06850168
- Acronym / sponsor ID
- WS10367
- Conditions
- Myopia
- Keywords
- Refractive error, Eye disease, Axial length, Myopia control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Feb 2025 (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.
The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:
Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children?
Researchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression.
Participants will:
- Wear the study spectacles
- Visit Essilor R\&D Centre for follow-up sessions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a 2-year, randomized, double-masked, contralateral, exploratory clinical trial with the objective to evaluate the efficacy of two test lenses designed with passive red-light emission in the control of myopia progression. The subject starts by wearing standard SVL, designed with passive red-light emission in one eye, and standard SVL in the contralateral eye. After 1 year, the eye wearing SVL designed with passive red-light emission will be replaced with standard MCL, and the contralateral eye will be replaced with standard MCL designed with passive red-light emission. At the end of the 2-year period, each eye would be exposed to lenses designed with passive red-light emission for 1 year each. There will be a total of 11 study visits with follow-up periods at 6 months, 12 months, 18 months and 24 months.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: SVL, Device: SVL with passive red-light emission, Device: MCL, Device: MCL with passive red-light emission(Year 1) OD: SVL with passive red-light emission; OS: SVL (Year 2) OD: MCL; OS: MCL with passive red-light emission |
| Group B | Experimental | Device: SVL, Device: SVL with passive red-light emission, Device: MCL, Device: MCL with passive red-light emission(Year 1) OD: SVL; OS: SVL with passive red-light emission (Year 2) OD: MCL with passive red-light emission; OS: MCL |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.
- Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.
- Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.
- Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen).
- Be in good general health, based on his/her and parent's/guardian's knowledge.
Key exclusion criteria (6 listed)
- Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.)
- Any binocular vision anomalies
- Amblyopia
- Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month.
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
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 |
|---|---|---|
| SVLDispensed to one eye in Year 1 | Device | Group A, Group B |
| SVL with passive red-light emissionDispensed to the contralateral eye in Year 1. | Device | Group A, Group B |
| MCLDispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1). | Device | Group A, Group B |
| MCL with passive red-light emissionDispensed to the contralateral eye in Year 2 (if used SVL in Year 1). | Device | Group A, Group B |
Primary outcome
Change in Axial Length
Time frame: From baseline to 12 months
Change in Axial Length
Time frame: From 12 months to 24 months
2 secondary outcomes
Change in Spherical Equivalent Refraction
Time frame: From baseline to 12 months
Change in Spherical Equivalent Refraction
Time frame: From 12 months to 24 months
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 7 Aug 2025.
- Background: PubMed 34863776Jiang Y, Zhu Z, Tan X, Kong X, Zhong H, Zhang J, Xiong R, Yuan Y, Zeng J, Morgan IG, He M. Effect of Repeated Low-Level Red-Light Therapy for Myopia Control in Children: A Multicenter Randomized Controlled Trial. Ophthalmology. 2022 May;129(5):509-519. doi: 10.1016/j.ophtha.2021.11.023. Epub 2021 Dec 1.
- Background: PubMed 36049646Dong J, Zhu Z, Xu H, He M. Myopia Control Effect of Repeated Low-Level Red-Light Therapy in Chinese Children: A Randomized, Double-Blind, Controlled Clinical Trial. Ophthalmology. 2023 Feb;130(2):198-204. doi: 10.1016/j.ophtha.2022.08.024. Epub 2022 Aug 29.
- Individual participant dataSharing planned: No
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
Thomas Boudenne contact
Andrew Tan principal investigator
Essilor R&D Centre Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SVL, SVL with passive red-light emission and MCL in people with Myopia, run by Essilor International at 1 site in Singapore.
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 7 inclusion and 6 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 7 Aug 2025. 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 Singapore. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Celine Carimalo (+65 67134617, carimalc@essilor.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Axial Length (time frame: From baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06850168, which also lists 2 linked publications.
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 7 Aug 2025.