MyopiaPEARLNCT07839091
Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia
A study testing Single Vision Spectacle Lens in people with Myopia and Myopia Progression, run by Essilor International at 1 site in Singapore.
Trial summary
The purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Myopia, Myopia Progression
- What is being tested?
- Single Vision Spectacle Lens
- 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
- Oct 2026to Jul 2028
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Volunteer participant with the willingness and ability to comply with all scheduled study visits.
- Informed consent of parent/guardian and assent of participant.
- Age equal to or greater than 6 years and less than 11 years (before 11th birthday) at the time of consent.
- Spherical equivalent refraction (SER) equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D.
- Difference in SER (anisometropia) between two eyes should not exceed 1.00 D.
- Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR under high contrast in each eye.
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- Be in good general health, based on the participant and the parent's/guardian's knowledge.
- Agree to wear the study spectacles for 12 hours per day and 7 days per week.
- Agree not to be involved in other myopia control treatments.
Who cannot join
- History of Atropine, Orthokeratology, Myopia Control Contact Lens, or Red Light treatment.
- Strabismus by cover test at near or distance wearing correction.
- History and presence of amblyopia.
- Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- History of ocular injury or surgery.
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- Participation in any clinical study within 30 days of the Baseline visit.
- Current or anticipated use of growth hormones.
- Study participants deemed inappropriate for the study by the investigator.
- The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.
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
Essilor R&D Centre Singapore
Singapore
Celine Carimalo, 67134617 ext. +65, carimalc@essilor.com.sg
About this study
Official title: A Paired-Eye Comparison of Myopia Control Lenses in Myopic Children
The purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years.
The main question being studied is:
Read more
Is the new myopia control spectacle lens more effective than a standard single vision spectacle lens in slowing myopia progression?
In this study, participants will wear a myopia control spectacle lens in one eye and a standard single vision spectacle lens in the other eye for the first 6 months. The lens assignment will then be switched between eyes for the remaining 6 months. Researchers will compare changes in eye axial length and refractive error between the two lens types.
Participants will:
- Wear the study spectacles for 12 months.
- Attend scheduled follow-up visits at the Essilor R\&D Centre, Singapore.
- Conditions
- Myopia, Myopia Progression
- Being tested
- Investigational Myopia Control Spectacle Lens, Single Vision Spectacle Lens
- Keywords
- refractive error, myopia control, axial length
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Myopia Control Spectacle LensDevice
A spectacle lens designed to help slow the progression of myopia in children
Single Vision Spectacle LensDevice
A standard spectacle lens used to correct refractive error without a specific myopia control feature
| Study group | Role | What they receive |
|---|---|---|
| OD: SVL; OS: MCL then OD: MCL; OS: SVL | Experimental | Participants will wear the investigational myopia control spectacle lens in the left eye and a standard single vision spectacle lens in the right eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months. Receives: Device: Investigational Myopia Control Spectacle Lens; Device: Single Vision Spectacle Lens |
| OD: MCL; OS: SVL then OD: SVL; OS: MCL | Experimental | Participants will wear the investigational myopia control spectacle lens in the right eye and a standard single vision spectacle lens in the left eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months. Receives: Device: Investigational Myopia Control Spectacle Lens; Device: Single Vision Spectacle Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eye Axial Length
Measured: From baseline to 6 months
Secondary outcomes (3)
Change in Eye Axial Length
Measured: From 6 months to 12 months
Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
Measured: From baseline to 6 months
Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
Measured: From 6 months to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJul 2028 (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 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
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT07839091
- Sponsor's protocol ID
- WS10528
- Acronym
- PEARL
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Paired-Eye Comparison of Myopia Control Lenses in Myopic Children
- ClinicalTrials.gov ID
- NCT07839091
- Acronym / sponsor ID
- PEARL / WS10528
- Conditions
- Myopia, Myopia Progression
- Keywords
- refractive error, myopia control, axial length
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 24 Sep 2026 (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 purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years.
The main question being studied is:
Is the new myopia control spectacle lens more effective than a standard single vision spectacle lens in slowing myopia progression?
In this study, participants will wear a myopia control spectacle lens in one eye and a standard single vision spectacle lens in the other eye for the first 6 months. The lens assignment will then be switched between eyes for the remaining 6 months. Researchers will compare changes in eye axial length and refractive error between the two lens types.
Participants will:
- Wear the study spectacles for 12 months.
- Attend scheduled follow-up visits at the Essilor R\&D Centre, Singapore.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OD: SVL; OS: MCL then OD: MCL; OS: SVL | Experimental | Device: Investigational Myopia Control Spectacle Lens, Device: Single Vision Spectacle LensParticipants will wear the investigational myopia control spectacle lens in the left eye and a standard single vision spectacle lens in the right eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months. |
| OD: MCL; OS: SVL then OD: SVL; OS: MCL | Experimental | Device: Investigational Myopia Control Spectacle Lens, Device: Single Vision Spectacle LensParticipants will wear the investigational myopia control spectacle lens in the right eye and a standard single vision spectacle lens in the left eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Volunteer participant with the willingness and ability to comply with all scheduled study visits.
- Informed consent of parent/guardian and assent of participant.
- Age equal to or greater than 6 years and less than 11 years (before 11th birthday) at the time of consent.
- Spherical equivalent refraction (SER) equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D.
- Difference in SER (anisometropia) between two eyes should not exceed 1.00 D.
Key exclusion criteria (10 listed)
- History of Atropine, Orthokeratology, Myopia Control Contact Lens, or Red Light treatment.
- Strabismus by cover test at near or distance wearing correction.
- History and presence of amblyopia.
- Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
- 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 |
|---|---|---|
| Investigational Myopia Control Spectacle LensA spectacle lens designed to help slow the progression of myopia in children | Device | OD: MCL; OS: SVL then OD: SVL; OS: MCL, OD: SVL; OS: MCL then OD: MCL; OS: SVL |
| Single Vision Spectacle LensA standard spectacle lens used to correct refractive error without a specific myopia control feature | Device | OD: MCL; OS: SVL then OD: SVL; OS: MCL, OD: SVL; OS: MCL then OD: MCL; OS: SVL |
Primary outcome
Change in Eye Axial Length
Time frame: From baseline to 6 months
3 secondary outcomes
Change in Eye Axial Length
Time frame: From 6 months to 12 months
Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
Time frame: From baseline to 6 months
Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
Time frame: From 6 months to 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 24 Sep 2026.
- 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.
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 Single Vision Spectacle Lens in people with Myopia and Myopia Progression, 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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 24 Sep 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?
Contact Celine Carimalo (67134617 ext. +65, 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 Eye Axial Length (time frame: From baseline to 6 months). 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 24 Sep 2026.