MyopiaNCT06857864
Exploratory Study on the Effectiveness of Myopia Control Lenses in Slowing Myopia Progression in Young Children
A study of Myopia, run by Essilor International at 1 site in Singapore.
Trial summary
This study will be a mono-center, single-arm, unmasked study evaluating the effectiveness of test lens in slowing myopia progression in children aged 6 to 8 years. The study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lens over a… Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSingapore
- Study dates
- 17 Mar 2025to Jul 2026
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form.
- Equal to or greater than 6 years and less than 9 years at time of informed consent and assent.
- Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye.
- Astigmatism, if present, of not more than 1.50 D.
- Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
- Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
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- Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status.
- Absence of strabismus by cover test at near or distance wearing correction.
- Absence of amblyopia
- Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
Who cannot join
- Vulnerability of subject
- History of myopia control intervention
- Participation in any clinical study within 30 days of the Baseline visit.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be a mono-center, single-arm, unmasked study evaluating the effectiveness of test lens in slowing myopia progression in children aged 6 to 8 years. The study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lens over a 1-year period. A total of 25 children will be recruited.
Read the detailed description
As myopia has become a global epidemic and public health concern, it is crucial to gain deeper insight to the possible treatments in slowing myopia progression. In a previous clinical trial, spectacle lenses with higher lenlets asphericity demonstrated effectiveness in reducing myopia progression and axial length elongation in children.
This clinical trial will assess the effectiveness of a test lens in slowing myopia progression in younger children over 1 year. Without compromising vision, the test lens is designed to modify the area and the amount of myopia defocus on the retina. The study population includes 25 children subjects in Singapore, aged 6 to 8 years during the commencement of the treatment. The axial length and spherical equivalent refraction will be the primary and secondary measures for myopia progression.
- Conditions
- Myopia
- Being tested
- Test myopia control lenses (BSL)
- Keywords
- Myopia, Refractive errors, Eye Diseases
- 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.
Test myopia control lenses (BSL)Device
Test spectacle lenses will be provided to the subjects throughout the 1 year clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| Test myopia control lenses (BSL) | Experimental | Test spectacle lens will be given to the subjects over 1 year. Receives: Device: Test myopia control lenses (BSL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Evaluate the change in axial length (mm)
Measured: 12 months
Secondary outcomes (2)
Axial length
Evaluate change in axial length (mm)
Measured: 6 months
Spherical Equivalent Refraction
Evaluate change in Spherical Equivalent Refraction (Diopters) through manifest subjective refraction
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start17 Mar 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a mono-center, single-arm, unmasked study consisting of 6 visits over 1 year. This study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lenses over a 1-year period. After obtaining informed consent and assent, a comprehensive eye examination will be conducted during the screening visit on all participants. Eligible participants, total of 25, between ages 6 to 8 years old will be enrolled into the study. On a separate visit, the enrolled subjects will return for a baseline visit to collect the study spectacles. During the baseline visit, instructions on study spectacles usage, assessment with study spectacles and ocular biometry will be conducted. Follow-up visits will be conducted at 3, 6 and 12 months' time, where 12 months is the end of study. All eye examinations and assessments are non-contact and non-invasive to the eyes.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857864
- Sponsor's protocol ID
- WS10441
- Status last verified
- Jul 2025
- First submitted
- 27 Feb 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.
PubMed 33811039
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Effectiveness of Myopia Control Lenses in Slowing Myopia Progression in Young Children
- ClinicalTrials.gov ID
- NCT06857864
- Acronym / sponsor ID
- WS10441
- Conditions
- Myopia
- Keywords
- Myopia, Refractive errors, Eye Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 4 Mar 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.
This study will be a mono-center, single-arm, unmasked study evaluating the effectiveness of test lens in slowing myopia progression in children aged 6 to 8 years. The study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lens over a 1-year period. A total of 25 children will be recruited.
Detailed description
As myopia has become a global epidemic and public health concern, it is crucial to gain deeper insight to the possible treatments in slowing myopia progression. In a previous clinical trial, spectacle lenses with higher lenlets asphericity demonstrated effectiveness in reducing myopia progression and axial length elongation in children.
This clinical trial will assess the effectiveness of a test lens in slowing myopia progression in younger children over 1 year. Without compromising vision, the test lens is designed to modify the area and the amount of myopia defocus on the retina. The study population includes 25 children subjects in Singapore, aged 6 to 8 years during the commencement of the treatment. The axial length and spherical equivalent refraction will be the primary and secondary measures for myopia progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a mono-center, single-arm, unmasked study consisting of 6 visits over 1 year. This study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lenses over a 1-year period. After obtaining informed consent and assent, a comprehensive eye examination will be conducted during the screening visit on all participants. Eligible participants, total of 25, between ages 6 to 8 years old will be enrolled into the study. On a separate visit, the enrolled subjects will return for a baseline visit to collect the study spectacles. During the baseline visit, instructions on study spectacles usage, assessment with study spectacles and ocular biometry will be conducted. Follow-up visits will be conducted at 3, 6 and 12 months' time, where 12 months is the end of study. All eye examinations and assessments are non-contact and non-invasive to the eyes.
| Arm | Type | Receives |
|---|---|---|
| Test myopia control lenses (BSL) | Experimental | Device: Test myopia control lenses (BSL)Test spectacle lens will be given to the subjects over 1 year. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form.
- Equal to or greater than 6 years and less than 9 years at time of informed consent and assent.
- Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye.
- Astigmatism, if present, of not more than 1.50 D.
- Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
Key exclusion criteria (3 listed)
- Vulnerability of subject
- History of myopia control intervention
- Participation in any clinical study within 30 days of the Baseline visit.
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 |
|---|---|---|
| Test myopia control lenses (BSL)Test spectacle lenses will be provided to the subjects throughout the 1 year clinical trial. | Device | Test myopia control lenses (BSL) |
Primary outcome
Axial length
Time frame: 12 months
Evaluate the change in axial length (mm)
2 secondary outcomes
Axial length
Time frame: 6 months
Spherical Equivalent Refraction
Time frame: 6 months, 12 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 20 Jul 2025.
- Background: PubMed 33811039Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of 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 10 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: 12 months). 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 NCT06857864, which also lists 1 linked publication.
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 20 Jul 2025.