MyopiaNCT06148870
Comparison of Efficacy Between Two Myopia Control Lenses
A study of Myopia, run by Essilor International at 1 site in Singapore.
Trial summary
This is a one-year, mono-centre, randomize, double-masked, monocular cross-over clinical trial designed to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopia progression. Read more about this study
- Who is it for?
- Ages 6 to 11 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
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Nov 2023to 3 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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 not older than 11 years at time of informed consent and assent.
- Spherical equivalent refractive error (SER) by manifest refraction between -0.50 and -4.75 D in each eye.
- Astigmatism, if present, of not more than 2.00 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 better than +0.20 logMAR
Show all 10Show fewer
- Agree to wear study spectacles for at least 10 hours a day and 6 days a week
- Willingness and ability to participate in trial for 1 year
- Willingness and ability to attend scheduled visits
- Not to involve concurrently in other myopia control treatments
Who cannot join
- History or presence of an Ocular disease, Strabismus, Amblyopia
- Undergoing any myopia control intervention specifically Atropine and Orthokeratology
- History of myopia control intervention specifically Atropine, Orthokeratology
Trial locations and contacts
1 site in 1 country.
About this study
This is a one-year, mono-centre, randomize, double-masked, monocular cross-over clinical trial designed to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopia progression.
Read the detailed description
The clinical trial aims to assess the safety and efficacy of a test lens, designed to modify the amount of myopic control signal on the retina without compromising vision. The primary goal of this clinical trial is to evaluate the effectiveness of the test lens in slowing down the increase of axial length and controlling myopia progression compared to the reference lens design.
- Conditions
- Myopia
- Being tested
- Myopia Control Lens-1 (MCL1), Myopia Control Lens-2 (MCL2)
- Keywords
- Refractive errors, Eye diseases, 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.
Myopia Control Lens-1 (MCL1)Device
The MCL1, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on one eye for 6 months.
Myopia Control Lens-2 (MCL2)Device
The MCL2, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on the contralateral eye for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| MCL1 | Active comparator | The MCL1 is a myopia control lens that will be worn in one eye for 6 months. Receives: Device: Myopia Control Lens-1 (MCL1); Device: Myopia Control Lens-2 (MCL2) |
| MCL2 | Experimental | The MCL2 is a myopia control lens that will be worn on the contralateral eye for 6 months. Receives: Device: Myopia Control Lens-1 (MCL1); Device: Myopia Control Lens-2 (MCL2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Axial Length
To evaluate the effectiveness of the MCL2 in slowing myopia progression with respect to the change in Axial Length (AL) from baseline compared to MCL1 at 12-month.
Measured: 12 months
Secondary outcomes (1)
Change in Spherical Equivalent Refraction
To evaluate the effectiveness of the MCL2 lens in slowing myopia progression with respect to the change in Spherical Equivalent Refraction (SER) from baseline compared to MCL1 at 12-month.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start29 Nov 2023
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Crossover
- Model description
- This is a one-year, mono-centre, randomized, double-masked, monocular cross-over Clinical Trial with the objective to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopic progression. The subject starts by wearing Myopia Control Lens 1 (MCL1) in one eye, and Myopia Control Lens 2 (MCL2) in another eye. After 6 months, a new pair of study spectacles will be dispensed with MCL1 and MCL2 crossed over. At the end of the 1-year period, each eye would have worn both MCL1 and MCL2 for 6 months each. There will be a total of 7 study visits with follow up periods at 3 months, 6 months and 12 months
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wee Sing Ong, Principal investigator, Essilor R&D Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148870
- Sponsor's protocol ID
- WS10356
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.
PubMed 26875007Bao J, Huang Y, Li X, Yang A, Zhou F, Wu J, Wang C, Li Y, Lim EW, Spiegel DP, Drobe B, Chen H. Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 May 1;140(5):472-478. doi: 10.1001/jamaophthalmol.2022.0401.
PubMed 35357402Smith EL 3rd. Optical treatment strategies to slow myopia progression: effects of the visual extent of the optical treatment zone. Exp Eye Res. 2013 Sep;114:77-88. doi: 10.1016/j.exer.2012.11.019. Epub 2013 Jan 3.
PubMed 23290590
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy Between Two Myopia Control Lenses
- ClinicalTrials.gov ID
- NCT06148870
- Acronym / sponsor ID
- WS10356
- Conditions
- Myopia
- Keywords
- Refractive errors, Eye diseases, Axial length, Myopia Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 28 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.
This is a one-year, mono-centre, randomize, double-masked, monocular cross-over clinical trial designed to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopia progression.
Detailed description
The clinical trial aims to assess the safety and efficacy of a test lens, designed to modify the amount of myopic control signal on the retina without compromising vision. The primary goal of this clinical trial is to evaluate the effectiveness of the test lens in slowing down the increase of axial length and controlling myopia progression compared to the reference lens design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a one-year, mono-centre, randomized, double-masked, monocular cross-over Clinical Trial with the objective to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopic progression. The subject starts by wearing Myopia Control Lens 1 (MCL1) in one eye, and Myopia Control Lens 2 (MCL2) in another eye. After 6 months, a new pair of study spectacles will be dispensed with MCL1 and MCL2 crossed over. At the end of the 1-year period, each eye would have worn both MCL1 and MCL2 for 6 months each. There will be a total of 7 study visits with follow up periods at 3 months, 6 months and 12 months
| Arm | Type | Receives |
|---|---|---|
| MCL1 | Active comparator | Device: Myopia Control Lens-1 (MCL1), Device: Myopia Control Lens-2 (MCL2)The MCL1 is a myopia control lens that will be worn in one eye for 6 months. |
| MCL2 | Experimental | Device: Myopia Control Lens-1 (MCL1), Device: Myopia Control Lens-2 (MCL2)The MCL2 is a myopia control lens that will be worn on the contralateral eye for 6 months. |
Who may qualify
- Ages
- 6 to 11 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 not older than 11 years at time of informed consent and assent.
- Spherical equivalent refractive error (SER) by manifest refraction between -0.50 and -4.75 D in each eye.
- Astigmatism, if present, of not more than 2.00 D.
- Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
Key exclusion criteria (3 listed)
- History or presence of an Ocular disease, Strabismus, Amblyopia
- Undergoing any myopia control intervention specifically Atropine and Orthokeratology
- History of myopia control intervention specifically Atropine, Orthokeratology
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 |
|---|---|---|
| Myopia Control Lens-1 (MCL1)The MCL1, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on one eye for 6 months. | Device | MCL1, MCL2 |
| Myopia Control Lens-2 (MCL2)The MCL2, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on the contralateral eye for 6 months. | Device | MCL1, MCL2 |
Primary outcome
Change in Axial Length
Time frame: 12 months
To evaluate the effectiveness of the MCL2 in slowing myopia progression with respect to the change in Axial Length (AL) from baseline compared to MCL1 at 12-month.
1 secondary outcome
Change in Spherical Equivalent Refraction
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 26875007Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.
- Background: PubMed 35357402Bao J, Huang Y, Li X, Yang A, Zhou F, Wu J, Wang C, Li Y, Lim EW, Spiegel DP, Drobe B, Chen H. Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 May 1;140(5):472-478. doi: 10.1001/jamaophthalmol.2022.0401.
- Background: PubMed 23290590Smith EL 3rd. Optical treatment strategies to slow myopia progression: effects of the visual extent of the optical treatment zone. Exp Eye Res. 2013 Sep;114:77-88. doi: 10.1016/j.exer.2012.11.019. Epub 2013 Jan 3.
- 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.
Wee Sing Ong 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 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: finished, as of the sponsor's last update on 23 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in 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 NCT06148870, which also lists 3 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 23 Jun 2026.