NCT06850168

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Jun 2025Dec 2027

First Submitted

Initial submission to the registry

February 24, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

June 26, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

2.3 years

First QC Date

February 24, 2025

Last Update Submit

August 4, 2025

Conditions

Myopia

Keywords

Refractive errorEye diseaseAxial lengthMyopia control

Outcome Measures

Primary Outcomes (2)

  • Change in Axial Length

    From baseline to 12 months

  • Change in Axial Length

    From 12 months to 24 months

Secondary Outcomes (2)

  • Change in Spherical Equivalent Refraction

    From baseline to 12 months

  • Change in Spherical Equivalent Refraction

    From 12 months to 24 months

Study Arms (2)

Group A

EXPERIMENTAL

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

Device: SVLDevice: SVL with passive red-light emissionDevice: MCLDevice: MCL with passive red-light emission

Group B

EXPERIMENTAL

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

Device: SVLDevice: SVL with passive red-light emissionDevice: MCLDevice: MCL with passive red-light emission

Interventions

SVLDEVICE

Dispensed to one eye in Year 1

Group AGroup B
SVL with passive red-light emissionDEVICE

Dispensed to the contralateral eye in Year 1.

Group AGroup B
MCLDEVICE

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

Group AGroup B
MCL with passive red-light emissionDEVICE

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

Group AGroup B

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Essilor R&D Centre Singapore

Singapore, Singapore

RECRUITING

Related Publications (2)

  • 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.

    PMID: 34863776BACKGROUND

  • 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.

    PMID: 36049646BACKGROUND

MeSH Terms

Conditions

MyopiaRefractive ErrorsEye Diseases

Study Officials

  • Andrew Tan

    Essilor R&D Centre Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Celine Carimalo

CONTACT

+65 67134617carimalc@essilor.com.sg

Thomas Boudenne

CONTACT

thomas.boudenne@essilor.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a 2-year, randomized, double-masked, contralateral, exploratory clinical trial with the objective to evaluate the efficacy of two test lenses designed with passive red-light emission in the control of myopia progression. The subject starts by wearing standard SVL, designed with passive red-light emission in one eye, and standard SVL in the contralateral eye. After 1 year, the eye wearing SVL designed with passive red-light emission will be replaced with standard MCL, and the contralateral eye will be replaced with standard MCL designed with passive red-light emission. At the end of the 2-year period, each eye would be exposed to lenses designed with passive red-light emission for 1 year each. There will be a total of 11 study visits with follow-up periods at 6 months, 12 months, 18 months and 24 months.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2025

First Posted

February 27, 2025

Study Start

June 26, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)