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

NCT06857864 | Active Not Recruiting

• 1 other identifier: WS10441
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia

Keywords

Myopia; Refractive errors; Eye Diseases

Outcome Measures

Primary Outcomes (1)

• Axial length

  Evaluate the change in axial length (mm)

  12 months

Secondary Outcomes (2)

• Axial length

  6 months

• Spherical Equivalent Refraction

  6 months, 12 months

Study Arms (1)

Test myopia control lenses (BSL)

EXPERIMENTAL

Test spectacle lens will be given to the subjects over 1 year.

Device: Test myopia control lenses (BSL)

Interventions

Test myopia control lenses (BSL) DEVICE

Test spectacle lenses will be provided to the subjects throughout the 1 year clinical trial.

Test myopia control lenses (BSL)

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Volunteer subject and guardian, fluent English spoken, willing to follow protocol and 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 consent and 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 not more 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 or systemic 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, may significantly affect pupil size, accommodation or refractive state.

You may not qualify if:

• Vulnerability of subject
• History of myopia control intervention
• Participation in any clinical study within 30 days of the Baseline visit.

Sponsors & Collaborators

• Essilor International: lead

Study Sites (1)

Essilor R&D Centre

Singapore, 339338, Singapore

Location

Related Publications (1)

• Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.

  PMID: 33811039 BACKGROUND

MeSH Terms

Conditions

Myopia; Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a mono-center, single-arm, unmasked study consisting of 6 visits over 1 year. This study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lenses over a 1-year period. After obtaining informed consent and assent, a comprehensive eye examination will be conducted during the screening visit on all participants. Eligible participants, total of 25, between ages 6 to 8 years old will be enrolled into the study. On a separate visit, the enrolled subjects will return for a baseline visit to collect the study spectacles. During the baseline visit, instructions on study spectacles usage, assessment with study spectacles and ocular biometry will be conducted. Follow-up visits will be conducted at 3, 6 and 12 months' time, where 12 months is the end of study. All eye examinations and assessments are non-contact and non-invasive to the eyes.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)