Comparison of Efficacy Between Two Myopia Control Lenses

Myopia Clinical Trial

Official title:

Comparison of Efficacy Between Two Myopia Control Lenses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06148870
• Other study ID #: WS10356
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: Essilor International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Singapore	Essilor R&D Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Essilor International

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Spherical Equivalent Refraction	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