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RecruitingNCT06850168Updated Aug 7, 2025

Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression

An interventional study of SVL and SVL with passive red-light emission in Myopia, sponsored by Essilor International. Recruiting at 1 site in Singapore. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-08-07.

Sponsored by Essilor International · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
6 Years to 11 Years
Sex
All
01

Study 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 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
02

Conditions studied

  • Myopia

Keywords

  • Refractive error
  • Eye disease
  • Axial length
  • Myopia control
03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's planned enrollment of 35 is below the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Essilor International is the lead sponsor of 38 studies on the registry; 20 are open to participants now.

Browse EssilorLuxottica studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children equal to or greater than 6 years old and less than 11 years at the time of signing .
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Group A

    (Year 1) OD: SVL with passive red-light emission; OS: SVL (Year 2) OD: MCL; OS: MCL with passive red-light emission

    Device: SVL · Device: SVL with passive red-light emission · Device: MCL · Device: MCL with passive red-light emission

  • Experimental
    Group B

    (Year 1) OD: SVL; OS: SVL with passive red-light emission (Year 2) OD: MCL with passive red-light emission; OS: MCL

    Device: SVL · Device: SVL with passive red-light emission · Device: MCL · Device: MCL with passive red-light emission

Interventions

  • DeviceSVL

    Dispensed to one eye in Year 1

  • DeviceSVL with passive red-light emission

    Dispensed to the contralateral eye in Year 1.

  • DeviceMCL

    Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).

  • DeviceMCL with passive red-light emission

    Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).

06

What researchers measure

Primary outcomes

  1. Change in Axial Length

    Time frame: From baseline to 12 months

  2. Change in Axial Length

    Time frame: From 12 months to 24 months

Secondary outcomes

  1. Change in Spherical Equivalent Refraction

    Time frame: From baseline to 12 months

  2. Change in Spherical Equivalent Refraction

    Time frame: From 12 months to 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 34863776 ↗
  • Dong 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Oct 2027, 28 months after the start.

Of 234 industry-sponsored interventional studies with no phase under Myopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 24. This study's planned 28 months is above that.

Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2025
First posted
Feb 27, 2025
StartActual
Jun 26, 2025
Primary completionEst.
Oct 2027
CompletionEst.
Dec 2027
Last update
Aug 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06850168
Lead sponsor
Essilor International
Responsible party
Sponsor
First posted
Feb 27, 2025
Start date
Jun 26, 2025
Primary completion
Oct 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 7, 2025

Study contacts

Celine Carimalo
Contact
carimalc@essilor.com.sg
+65 67134617
Thomas Boudenne
Contact
thomas.boudenne@essilor.com
Andrew Tan
principal investigator · Essilor R&D Centre Singapore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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