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Recruiting

NCT Number: NCT06850168

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

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

Recruiting

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Key information

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Essilor R&D Centre Singapore

Singapore

Location status: Recruiting

Location contact

Celine Carimalo

CONTACT

[email protected]

67134617

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SVL

Device

Dispensed to one eye in Year 1

SVL with passive red-light emission

Device

Dispensed to the contralateral eye in Year 1.

MCL

Device

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

MCL with passive red-light emission

Device

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Celine Carimalo

CONTACT

[email protected]

+65 67134617

Thomas Boudenne

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Essilor International

Industry

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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