Study Comparing Eye Growth Over Time in Children Using Two Myopia Control Lenses

NCT07253064 | Recruiting

• 1 other identifier: WS10449
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the short-term changes in the eye structure while wearing two types of lenslet-based myopia control lenses over a period of 6 months in children aged 6 to 13 years with myopia. The main question it aims to answer is:

• Wear the study spectacles
• Visit Essilor R\&D Centre for follow-up sessions

Conditions

Myopia

Keywords

myopia control; axial length; choroidal thickness

Outcome Measures

Primary Outcomes (1)

• Change in Axial Length

  Baseline, 1 hour post-dispense, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, and 24 weeks post-dispense.

Secondary Outcomes (1)

• Change in Choroidal Thickness

  Baseline, 1 hour post-dispense, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, and 24 weeks post-dispense.

Study Arms (2)

OD: MCL 1; OS: MCL 2

EXPERIMENTAL

Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 1, MCL 1 will be worn in the right eye, and MCL 2 in the left eye for a period of 6 months.

Device: MCL 1; Device: MCL 2

OD: MCL 2; OS: MCL 1

EXPERIMENTAL

Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 2, MCL 2 will be worn in the right eye, and MCL 1 in the left eye for a period of 6 months.

Device: MCL 1; Device: MCL 2

Interventions

MCL 1 DEVICE

Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months.

OD: MCL 1; OS: MCL 2; OD: MCL 2; OS: MCL 1

MCL 2 DEVICE

Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months.

OD: MCL 1; OS: MCL 2; OD: MCL 2; OS: MCL 1

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Volunteer participant
• Informed consent of parent or guardian and assent of participant
• Age: Equal to or greater than 6 years but not older than 13 years at the time of informed consent and assent.
• Refractive error (manifest refraction):
• Equal or less than -0.50 D or equal or greater than -4.75D.
• Astigmatism should be less than or equal to 2.00D.
• Anisometropia should be less than or equal to 1.00D
• Best corrected visual acuity: Better than 0.2 logMAR in each eye
• Willingness and ability to:
• participate in trial for at least 6 months.
• attend scheduled visits.
• not to be involved in other myopia control treatments concurrently.
• No history of any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)

You may not qualify if:

• History or presence of:
• An ocular disease
• Strabismus
• Amblyopia
• Currently or previously on any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)

Sponsors & Collaborators

• Essilor International: lead

Study Sites (1)

Essilor R&D Centre Singapore

Singapore, Singapore

RECRUITING

Related Publications (2)

• Li X, Huang Y, Liu C, Chang X, Cui Z, Yang Q, Drobe B, Bullimore MA, Chen H, Bao J. Myopia control efficacy of spectacle lenses with highly aspherical lenslets: results of a 5-year follow-up study. Eye Vis (Lond). 2025 Mar 5;12(1):10. doi: 10.1186/s40662-025-00427-3.

  PMID: 40038807 BACKGROUND

• Lau JK, Wan K, Cheung SW, Vincent SJ, Cho P. Weekly Changes in Axial Length and Choroidal Thickness in Children During and Following Orthokeratology Treatment With Different Compression Factors. Transl Vis Sci Technol. 2019 Jul 23;8(4):9. doi: 10.1167/tvst.8.4.9. eCollection 2019 Jul.

  PMID: 31360614 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Aparna Gopalakrishnan

  Essilor R&D Centre Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celine Carimalo

CONTACT

+65 67134600; carimalc@essilor.com.sg

Thomas Boudenne

CONTACT

thomas.boudenne@essilor.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: November 28, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)