Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

A Double-masked, Randomized, 2-armed Comparative Study of a Myopia Control Lens (Test Lens) Versus Single Vision Lens (Control Lens).

This is a monocenter, randomized, controlled, parallel-group, double-masked clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation at baseline compared to a single vision spectacle lens (control). A total of 80 children will be recruited where 40 subjects will be allocated either to wear test lenses (group 1) or control lenses (group 2) for 1 year through randomization.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia; Myopia, Progressive
• Intervention / Treatment: Device: Test myopia control lenses; Device: Single vision lenses

Detailed Description

As myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. Spectacle lenses with aspherical lenslets were shown to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial. A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy.

This double masked parallel group study will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. The study population includes children in Singapore aged 8 to 13 years (80 subjects) at the time of commencing treatment. As age of myopia onset is known to be an important factor in rate of myopia progression, subject age at the time of enrollment will be used to balance randomization. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuity will also be compared between test lenses and control lenses to determine the quality of vision using test lenses.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 339346
    • Essilor R&D Centre Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 8 years and not older than 13 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.
• History of myopia control intervention
• 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.

Exclusion Criteria

• Vulnerability of subject
• Participation in any clinical study within 30 days of the Baseline visit.
• Sibling of existing participant of this study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test myopia control lenses; A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.	Device: Test myopia control lenses; A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.
Other: Single vision lenses; A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.	Device: Single vision lenses; A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial Length	Change in ocular axial length (mm) measured using Lenstar Optical Biometer.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spherical Equivalent Refraction	Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction.	6 months and 12 months
Axial Length	Change in ocular axial length (mm) measured using Lenstar Optical Biometer.	6 months
Carry-over Effect	Change in ocular axial length (mm) measured using Lenstar Optical Biometer after switching to STELLEST™ lenses	18 months and 24 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): October 29, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: myopia progression; refractive error; eye disease; short-sightedness; children myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative
• Other Study ID Numbers: WS10258

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No