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OpenTrials
Completed

NCT Number: NCT06148870

Comparison of Efficacy Between Two Myopia Control Lenses

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Essilor R&D Centre Singapore

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myopia Control Lens-1 (MCL1)

Device

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.

Myopia Control Lens-2 (MCL2)

Device

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.

Primary outcomes

  1. Change in Axial Length

    Time frame: 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 outcomes

  1. Change in Spherical Equivalent Refraction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Essilor International

Industry

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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