Comparison of Efficacy Between Two Myopia Control Lenses

• Sponsor: Essilor International (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06148870
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Myopia Control Lens-1 (MCL1); Device: Myopia Control Lens-2 (MCL2)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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 monthsThis 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 (Participant, Investigator)
• Masking Description: As this is a double-masked, randomized controlled trial, both the investigators and subjects will be masked.
• Primary Purpose: Treatment
• Official Title: Comparison of Efficacy Between Two Myopia Control Lenses
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2025
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Essilor R&D Centre Singapore	Singapore		Singapore

Sponsors and Collaborators

• Essilor International

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bao J, Huang Y, Li X, Yang A, Zhou F, Wu J, Wang C, Li Y, Lim EW, Spiegel DP, Drobe B, Chen H. Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 May 1;140(5):472-478. doi: 10.1001/jamaophthalmol.2022.0401.
• Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.
• Smith EL 3rd. Optical treatment strategies to slow myopia progression: effects of the visual extent of the optical treatment zone. Exp Eye Res. 2013 Sep;114:77-88. doi: 10.1016/j.exer.2012.11.019. Epub 2013 Jan 3.

• Responsible Party: Essilor International
• ClinicalTrials.gov Identifier: NCT06148870
• Other Study ID Numbers: WS10356
• First Posted: Nov 28, 2023
• Last Update Posted: Nov 29, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Essilor International: Refractive errors; Eye diseases; Axial length; Myopia Control
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Nov 29, 2023