Exploratory Study on the Effectiveness of Myopia Control Lenses in Slowing Myopia Progression in Young Children

Last updated: April 1, 2025
Sponsor: Essilor International
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

Test myopia control lenses (BSL)

Clinical Study ID

NCT06857864
WS10441
  • Ages 6-8
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will be a mono-center, single-arm, unmasked study evaluating the effectiveness of test lens in slowing myopia progression in children aged 6 to 8 years. The study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lens over a 1-year period. A total of 25 children will be recruited.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Volunteer subject and guardian, fluent English spoken, willing to follow protocoland able to read, comprehend and sign the informed consent & assent form.

  • Equal to or greater than 6 years and less than 9 years at time of informed consentand assent.

  • Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye.

  • Astigmatism, if present, of not more than 1.50 D.

  • Difference in SER between the two eyes (Anisometropia) by manifest refraction notmore than 1.00 D.

  • Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)

  • Be in good general health based on his/her and parent's/guardian's knowledge.Absence of ocular disease with full ophthalmic examination. Without any ocular orsystemic condition known to affect refractive status.

  • Absence of strabismus by cover test at near or distance wearing correction.

  • Absence of amblyopia

  • Without ocular or systemic medications which, in the investigator's opinion, maysignificantly affect pupil size, accommodation or refractive state.

Exclusion

Exclusion Criteria:

  • Vulnerability of subject

  • History of myopia control intervention

  • Participation in any clinical study within 30 days of the Baseline visit.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Test myopia control lenses (BSL)
Phase:
Study Start date:
March 17, 2025
Estimated Completion Date:
July 31, 2026

Study Description

As myopia has become a global epidemic and public health concern, it is crucial to gain deeper insight to the possible treatments in slowing myopia progression. In a previous clinical trial, spectacle lenses with higher lenlets asphericity demonstrated effectiveness in reducing myopia progression and axial length elongation in children.

This clinical trial will assess the effectiveness of a test lens in slowing myopia progression in younger children over 1 year. Without compromising vision, the test lens is designed to modify the area and the amount of myopia defocus on the retina. The study population includes 25 children subjects in Singapore, aged 6 to 8 years during the commencement of the treatment. The axial length and spherical equivalent refraction will be the primary and secondary measures for myopia progression.

Connect with a study center

  • Essilor R&D Centre

    Singapore, 339338
    Singapore

    Active - Recruiting

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