Comparison of Efficacy Between Two Myopia Control Lenses

Essilor

Status: Active, not recruiting

Conditions: Myopia

Treatments: Device: Myopia Control Lens-2 (MCL2); Device: Myopia Control Lens-1 (MCL1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06148870

WS10356

Details and patient eligibility

About

This is a one-year, mono-centre, randomize, double-masked, monocular cross-over clinical trial designed to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopia progression.

Full description

The clinical trial aims to assess the safety and efficacy of a test lens, designed to modify the amount of myopic control signal on the retina without compromising vision. The primary goal of this clinical trial is to evaluate the effectiveness of the test lens in slowing down the increase of axial length and controlling myopia progression compared to the reference lens design.

Enrollment: 50 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: Accepts Healthy Volunteers

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 6 years and not older than 11 years at time of informed consent and assent.
• Spherical equivalent refractive error (SER) by manifest refraction between -0.50 and -4.75 D in each eye.
• Astigmatism, if present, of not more than 2.00 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 better than +0.20 logMAR
• Agree to wear study spectacles for at least 10 hours a day and 6 days a week
• Willingness and ability to participate in trial for 1 year
• Willingness and ability to attend scheduled visits
• Not to involve concurrently in other myopia control treatments

Exclusion criteria

• History or presence of an Ocular disease, Strabismus, Amblyopia
• Undergoing any myopia control intervention specifically Atropine and Orthokeratology
• History of myopia control intervention specifically Atropine, Orthokeratology

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

MCL1

Active Comparator group

Description:

The MCL1 is a myopia control lens that will be worn in one eye for 6 months.

Treatment:

Device: Myopia Control Lens-2 (MCL2)

Device: Myopia Control Lens-1 (MCL1)

MCL2

Experimental group

Description:

The MCL2 is a myopia control lens that will be worn on the contralateral eye for 6 months.

Treatment:

Device: Myopia Control Lens-2 (MCL2)

Device: Myopia Control Lens-1 (MCL1)