Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

NCT05331378 | Active Not Recruiting

• 1 other identifier: WS10258
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia, Progressive; Myopia

Keywords

refractive error; eye disease; short-sightedness; children myopia; myopia progression

Outcome Measures

Primary Outcomes (1)

• Axial Length

  Change in ocular axial length (mm) measured using Lenstar Optical Biometer.

  12 months

Secondary Outcomes (3)

• Spherical Equivalent Refraction

  6 months and 12 months

• Axial Length

  6 months

• Carry-over Effect

  18 months and 24 months

Study Arms (2)

Test myopia control lenses

EXPERIMENTAL

A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.

Device: Test myopia control lenses

Single vision lenses

OTHER

A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.

Device: Single vision lenses

Interventions

Test myopia control lenses DEVICE

A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.

Test myopia control lenses

Single vision lenses DEVICE

A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.

Single vision lenses

Eligibility Criteria

• Age: 8 Years - 13 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 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.

You may not qualify if:

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

Sponsors & Collaborators

• Essilor International: lead

Study Sites (1)

Essilor R&D Centre Singapore

Singapore, 339346, 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, Degenerative; Myopia; Refractive Errors; Eye Diseases

Study Officials

• Andrew Tan

  Essilor R&D Centre Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects (and their parents/guardians) will be masked to the lens assignment. Sibling of subjects must be excluded due to the noticeable differences between the test and control spectacle lenses Only the statistician will be unmasked when comparing the two lenses. The investigator who is responsible for randomization and allocation will also be unmasked. However, the primary outcome variables (spherical equivalent refraction \& axial length) will be taken by masked investigators. To facilitate this, the subject will be led into the room(s) containing a biometer without their study spectacles by the unmasked investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, controlled, 2-armed, double-masked, monocenter, clinical trial, which consists of 6 visits across 1 year. The test myopia control lens will be compared with a single vision control lens in evaluating study objectives. After obtaining informed consent and assent, a comprehensive eye examination for screening will be done among approximately 80 myopic children between the age of 8-13 years old for eligibility. After randomization, the subjects will be back for dispensing of study spectacles and for baseline visit, where assessment of study spectacles, biometry, and instructions to use study spectacles were done. A follow up visit will be conducted in 3, 6 and 12 months time, in which the latter visit will also be the end of visit. All of which are non-contact and non-invasive to the eyes.

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: April 25, 2022
• Primary Completion: October 29, 2024
• Study Completion: October 1, 2025
• Last Updated: August 7, 2025

Record last verified: 2024-08

Locations

SG (1)