Comparison of Efficacy Between Two Myopia Control Lenses

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Efficacy Between Two Myopia Control Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Myopia Control Lens-1 (MCL1)
* Device: Myopia Control Lens-2 (MCL2)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a one-year, mono-centre, randomized, double-masked, monocular cross-over Clinical Trial with the objective to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopic progression. The subject starts by wearing Myopia Control Lens 1 (MCL1) in one eye, and Myopia Control Lens 2 (MCL2) in another eye. After 6 months, a new pair of study spectacles will be dispensed with MCL1 and MCL2 crossed over. At the end of the 1-year period, each eye would have worn both MCL1 and MCL2 for 6 months each. There will be a total of 7 study visits with follow up periods at 3 months, 6 months and 12 months
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MCL1<br>The MCL1 is a myopia control lens that will be worn in one eye for 6 months. | Device: Myopia Control Lens-1 (MCL1)<br>* The MCL1, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on one eye for 6 months.<br>Device: Myopia Control Lens-2 (MCL2)<br>* The MCL2, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on the contralateral eye for 6 months.<br>|
| Experimental: MCL2<br>The MCL2 is a myopia control lens that will be worn on the contralateral eye for 6 months. | Device: Myopia Control Lens-1 (MCL1)<br>* The MCL1, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on one eye for 6 months.<br>Device: Myopia Control Lens-2 (MCL2)<br>* The MCL2, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on the contralateral eye for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Axial Length | To evaluate the effectiveness of the MCL2 in slowing myopia progression with respect to the change in Axial Length (AL) from baseline compared to MCL1 at 12-month. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Spherical Equivalent Refraction | To evaluate the effectiveness of the MCL2 lens in slowing myopia progression with respect to the change in Spherical Equivalent Refraction (SER) from baseline compared to MCL1 at 12-month. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractive errors, Eye diseases, Axial length, Myopia Control