Comparison of Efficacy Between Two Myopia Control Lenses

Not Applicable

Active, not recruiting

• Conditions: Myopia

• Registration Number: NCT06148870
• Lead Sponsor: Essilor International

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-11-27
• Study First Posted: 2023-11-28
• Study Start: 2023-11-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-02
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Axial Length	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Spherical Equivalent Refraction	12 months	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.

Trial Locations

Locations (1)

Essilor R&D Centre Singapore; 🇸🇬 Singapore, Singapore