MyopiaNCT07253064
Study Comparing Eye Growth Over Time in Children Using Two Myopia Control Lenses
A study testing MCL 1 and MCL 2 in people with Myopia, run by Essilor International at 1 site in Singapore.
Trial summary
The goal of this clinical trial is to investigate the short-term changes in the eye structure while wearing two types of lenslet-based myopia control lenses over a period of 6 months in children aged 6 to 13 years with myopia. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Myopia
- What is being tested?
- MCL 1 and MCL 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Nov 2025to Sep 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Volunteer participant
- Informed consent of parent or guardian and assent of participant
- Age: Equal to or greater than 6 years but not older than 13 years at the time of informed consent and assent.
- Refractive error (manifest refraction):
- Equal or less than -0.50 D or equal or greater than -4.75D.
- Astigmatism should be less than or equal to 2.00D.
Show all 13Show fewer
- Anisometropia should be less than or equal to 1.00D
- Best corrected visual acuity: Better than 0.2 logMAR in each eye
- Willingness and ability to:
- participate in trial for at least 6 months.
- attend scheduled visits.
- not to be involved in other myopia control treatments concurrently.
- No history of any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)
Who cannot join
- History or presence of:
- An ocular disease
- Strabismus
- Amblyopia
- Currently or previously on any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Monocentre, Randomized, Contralateral Trial to Study the Effect of Temporal Changes in Ocular Biometry of Two Myopia Control Lenses
The goal of this clinical trial is to investigate the short-term changes in the eye structure while wearing two types of lenslet-based myopia control lenses over a period of 6 months in children aged 6 to 13 years with myopia. The main question it aims to answer is:
- How the eye responds, at each timepoint, to the two myopia control lenses by evaluating:
- Change in axial length
- Change in choroidal thickness Participants will:
- Wear the study spectacles
- Visit Essilor R\&D Centre for follow-up sessions
- Conditions
- Myopia
- Being tested
- MCL 1, MCL 2
- Keywords
- myopia control, axial length, choroidal thickness
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCL 1Device
Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months.
MCL 2Device
Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| OD: MCL 1; OS: MCL 2 | Experimental | Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 1, MCL 1 will be worn in the right eye, and MCL 2 in the left eye for a period of 6 months. Receives: Device: MCL 1; Device: MCL 2 |
| OD: MCL 2; OS: MCL 1 | Experimental | Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 2, MCL 2 will be worn in the right eye, and MCL 1 in the left eye for a period of 6 months. Receives: Device: MCL 1; Device: MCL 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Axial Length
Measured: Baseline, 1 hour post-dispense, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, and 24 weeks post-dispense.
Secondary outcomes (1)
Change in Choroidal Thickness
Measured: Baseline, 1 hour post-dispense, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, and 24 weeks post-dispense.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start11 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aparna Gopalakrishnan, Principal investigator, Essilor R&D Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253064
- Sponsor's protocol ID
- WS10449
- Status last verified
- Nov 2025
- First submitted
- 29 Sep 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Huang Y, Liu C, Chang X, Cui Z, Yang Q, Drobe B, Bullimore MA, Chen H, Bao J. Myopia control efficacy of spectacle lenses with highly aspherical lenslets: results of a 5-year follow-up study. Eye Vis (Lond). 2025 Mar 5;12(1):10. doi: 10.1186/s40662-025-00427-3.
PubMed 40038807Lau JK, Wan K, Cheung SW, Vincent SJ, Cho P. Weekly Changes in Axial Length and Choroidal Thickness in Children During and Following Orthokeratology Treatment With Different Compression Factors. Transl Vis Sci Technol. 2019 Jul 23;8(4):9. doi: 10.1167/tvst.8.4.9. eCollection 2019 Jul.
PubMed 31360614
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
- A Monocentre, Randomized, Contralateral Trial to Study the Effect of Temporal Changes in Ocular Biometry of Two Myopia Control Lenses
- ClinicalTrials.gov ID
- NCT07253064
- Acronym / sponsor ID
- WS10449
- Conditions
- Myopia
- Keywords
- myopia control, axial length, choroidal thickness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 28 Nov 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 clinical trial is to investigate the short-term changes in the eye structure while wearing two types of lenslet-based myopia control lenses over a period of 6 months in children aged 6 to 13 years with myopia. The main question it aims to answer is:
- How the eye responds, at each timepoint, to the two myopia control lenses by evaluating:
- Change in axial length
- Change in choroidal thickness 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
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OD: MCL 1; OS: MCL 2 | Experimental | Device: MCL 1, Device: MCL 2Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 1, MCL 1 will be worn in the right eye, and MCL 2 in the left eye for a period of 6 months. |
| OD: MCL 2; OS: MCL 1 | Experimental | Device: MCL 1, Device: MCL 2Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 2, MCL 2 will be worn in the right eye, and MCL 1 in the left eye for a period of 6 months. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Volunteer participant
- Informed consent of parent or guardian and assent of participant
- Age: Equal to or greater than 6 years but not older than 13 years at the time of informed consent and assent.
- Refractive error (manifest refraction):
- Anisometropia should be less than or equal to 1.00D
Key exclusion criteria (5 listed)
- History or presence of:
- Currently or previously on any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)
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 |
|---|---|---|
| MCL 1Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months. | Device | OD: MCL 1; OS: MCL 2, OD: MCL 2; OS: MCL 1 |
| MCL 2Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months. | Device | OD: MCL 1; OS: MCL 2, OD: MCL 2; OS: MCL 1 |
Primary outcome
Change in Axial Length
Time frame: Baseline, 1 hour post-dispense, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, and 24 weeks post-dispense.
1 secondary outcome
Change in Choroidal Thickness
Time frame: Baseline, 1 hour post-dispense, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, and 24 weeks post-dispense.
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 23 Jun 2026.
- Background: PubMed 40038807Li X, Huang Y, Liu C, Chang X, Cui Z, Yang Q, Drobe B, Bullimore MA, Chen H, Bao J. Myopia control efficacy of spectacle lenses with highly aspherical lenslets: results of a 5-year follow-up study. Eye Vis (Lond). 2025 Mar 5;12(1):10. doi: 10.1186/s40662-025-00427-3.
- Background: PubMed 31360614Lau JK, Wan K, Cheung SW, Vincent SJ, Cho P. Weekly Changes in Axial Length and Choroidal Thickness in Children During and Following Orthokeratology Treatment With Different Compression Factors. Transl Vis Sci Technol. 2019 Jul 23;8(4):9. doi: 10.1167/tvst.8.4.9. eCollection 2019 Jul.
- Individual participant dataSharing planned: No
Related trials for Myopia
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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.
Aparna Gopalakrishnan 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 MCL 1 and MCL 2 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 13 inclusion and 5 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 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?
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?
Change in Axial Length (time frame: Baseline, 1 hour post-dispense, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, and 24 weeks post-dispense.). 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 NCT07253064, 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 23 Jun 2026.