Comparison of Efficacy Between Two Myopia Control Lenses

NCT06148870 | Active Not Recruiting

• 1 other identifier: WS10356
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

Refractive errors; Eye diseases; Axial length; Myopia Control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Spherical Equivalent Refraction

  12 months

Study Arms (2)

MCL1

ACTIVE COMPARATOR

The MCL1 is a myopia control lens that will be worn in one eye for 6 months.

Device: Myopia Control Lens-1 (MCL1); Device: Myopia Control Lens-2 (MCL2)

MCL2

EXPERIMENTAL

The MCL2 is a myopia control lens that will be worn on the contralateral eye for 6 months.

Device: Myopia Control Lens-1 (MCL1); Device: Myopia Control Lens-2 (MCL2)

Interventions

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.

MCL1; MCL2

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.

MCL1; MCL2

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Essilor International: lead

Study Sites (1)

Essilor R&D Centre Singapore

Singapore, Singapore

Location

Related Publications (3)

• 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.

  PMID: 26875007 BACKGROUND

• 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.

  PMID: 35357402 BACKGROUND

• 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.

  PMID: 23290590 BACKGROUND

MeSH Terms

Conditions

Myopia; Refractive Errors; Eye Diseases

Study Officials

• Wee Sing Ong

  Essilor R&D Centre Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: As this is a double-masked, randomized controlled trial, both the investigators and subjects will be masked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: November 29, 2023
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)