Evaluation of the Effectiveness of a New Generation of Myopia Control Lens on the Progression of Myopia in Children Aged 6 to 14 Years

NCT07462897 | Recruiting

• 2 other identifiers: WS104422025-A02213-46
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical investigation is to learn how much a new generation of myopia control lens (MCL1 - Myopia Control Lens 1) is helpful in reducing myopia progression in children from 6 to 14 yo. The main questions it aims to answer is: How much this new generation of lens, called MCL1, slows down the growth of the eye? Researchers will compare MCL1 to a former generation of myopia control lens (i.e. MCL2) but with better vision quality. Participants will:

• Wear MCL1 on right eye and MCL2 on left eye for 6 months and MCL2 on rigth eye and MCL1 on left eye for the next 6 months;
• Visit the hospital at 6 and 12 months for tests;
• Answer weekly questionnaires on compliance wearing glasses, quality of vision and out-of-school activities.

Conditions

Myopia Progression

Outcome Measures

Primary Outcomes (1)

• Change from baseline in axial length

  6-month

Secondary Outcomes (3)

• Change from baseline in cycloplegic spherical equivalent

  6-month

• Effect of optical parameters, assessed at baseline, on myopia control efficacy of MCL1 and MCL2 at 6-month.

  6-month

• Effect of self-reported exposure time to natural light on myopia control efficacy of MCL1 and MCL2 at 6-month

  6-month

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: MCL1; Device: MCL2

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: MCL1; Device: MCL2

Interventions

MCL1 DEVICE

Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children.

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

MCL2 DEVICE

Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children.

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

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Refractive error in spherical equivalent (SE) ≤ -0.5 D and ≥ -4.5 D on each eye (autorefraction under cycloplegia)
• Astigmatism ≤ 2.00 D for each eye
• Anisometropia (difference in SE between the 2 eyes) ≤ 1.00 D
• Corrected maximum distance visual acuity in each eye≥ 8/10 (equivalent to +0.1 LogMAR)
• Written consent of the 2 holders of parental authority (or only one in the case of exclusive parental authority) and agreement of the participant

You may not qualify if:

• Past or current use of any type of myopic control solution (braking lenses, atropine, orthokeratology, multifocal contact lenses, etc
• Strabismus (in the test of masking near or far with the best correction)
• Amblyopia
• Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down syndrome, etc.)
• Presence of trauma in at least one eye - Presence of inflammatory pathologies in at least one eye
• History of intraocular surgery (cataracts, filtering surgery, intravitreal surgery) in at least one eye
• Past or current use of growth hormones
• Use of ocular or systemic drugs that, in the opinion of the investigator, may significantly affect pupil size, accommodation, or refractive status.
• Wearing contact lenses
• Allergy or intolerance to cycloplegic eye drops (cyclopentolate 0.5%)
• Known allergy or intolerance to eyeglass frame materials
• Children with specific visual disorders requiring personalized treatments other than conventional corrective lenses.
• Intolerance to conventional optical corrections
• Lack of cooperation in wearing corrective lenses

Sponsors & Collaborators

• Essilor International: lead

Study Sites (1)

Département d'Ophtalmologie, Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

RECRUITING

Central Study Contacts

Thibaut Chapron, MD

CONTACT

00331 48 03 65 56; tchapron@for.paris

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 10, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)