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

August 4, 2025 updated by: Essilor International

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The clinical trial aims to assess the efficacy and safety of a test lens, designed to emit red-light when exposed to natural daylight that can produce a cumulative red-light exposure equivalent to the sham device (Dong et. al, 2023) when children spend about 30 minutes in a day. 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 Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Dispensed to one eye in Year 1
Device: SVL with passive red-light emission
Dispensed to the contralateral eye in Year 1.
Device: MCL
Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).
Device: MCL with passive red-light emission
Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).
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
Dispensed to one eye in Year 1
Device: SVL with passive red-light emission
Dispensed to the contralateral eye in Year 1.
Device: MCL
Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).
Device: MCL with passive red-light emission
Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Axial Length
Time Frame: From baseline to 12 months
From baseline to 12 months
Change in Axial Length
Time Frame: From 12 months to 24 months
From 12 months to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Spherical Equivalent Refraction
Time Frame: From baseline to 12 months
From baseline to 12 months
Change in Spherical Equivalent Refraction
Time Frame: From 12 months to 24 months
From 12 months to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Essilor International

Investigators

  • Principal Investigator: Andrew Tan, Essilor R&D Centre Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS10367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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