Comparison of Efficacy Between Two Myopia Control Lenses

February 15, 2024 updated by: Essilor International
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore
        • Essilor R&D Centre Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MCL1
The MCL1 is a myopia control lens that will be worn in one eye for 6 months.
Device: Myopia Control Lens-1 (MCL1)
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.
Device: Myopia Control Lens-2 (MCL2)
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.
Experimental: MCL2
The MCL2 is a myopia control lens that will be worn on the contralateral eye for 6 months.
Device: Myopia Control Lens-1 (MCL1)
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.
Device: Myopia Control Lens-2 (MCL2)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Essilor International

Investigators

  • Principal Investigator: Wee Sing Ong, Essilor R&D Centre Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS10356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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