Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

Sponsor

Essilor International (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05331378

Collaborator

(none)

Enrollment

Location

Arms

13.2

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a monocenter, randomized, controlled, parallel-group, double-masked clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation at baseline compared to a single vision spectacle lens (control). A total of 80 children will be recruited where 40 subjects will be allocated either to wear test lenses (group 1) or control lenses (group 2) for 1 year through randomization.

Condition or Disease	Intervention/Treatment	Phase
Myopia, Progressive Myopia	Device: Test myopia control lenses Device: Single vision lenses	N/A

Detailed Description

As myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. Spectacle lenses with aspherical lenslets were shown to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial. A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy.

This double masked parallel group study will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. The study population includes children in Singapore aged 8 to 13 years (80 subjects) at the time of commencing treatment. As age of myopia onset is known to be an important factor in rate of myopia progression, subject age at the time of enrollment will be used to balance randomization. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuity will also be compared between test lenses and control lenses to determine the quality of vision using test lenses.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a randomized, controlled, parallel-group, double-masked, monocenter, clinical trial, which consists of 6 visits, across 12 months. The test myopia control spectacle lens will be compared with a single vision control spectacle lens in evaluating study objectives. After obtaining informed consent and assent, a comprehensive eye examination for screening will be done among approximately 80 myopic children between the age of 8 to 13 years old for eligibility. After randomization, the subjects will be back for dispensing of study spectacles and for baseline visit, where assessment of study spectacles, biometry, and instructions to use study spectacles were done. A follow up visit will be conducted in 3, 6 and 12 months time, in which the latter visit will also be the end of visit. All of which are non-contact and non-invasive to the eyes.This is a randomized, controlled, parallel-group, double-masked, monocenter, clinical trial, which consists of 6 visits, across 12 months. The test myopia control spectacle lens will be compared with a single vision control spectacle lens in evaluating study objectives. After obtaining informed consent and assent, a comprehensive eye examination for screening will be done among approximately 80 myopic children between the age of 8 to 13 years old for eligibility. After randomization, the subjects will be back for dispensing of study spectacles and for baseline visit, where assessment of study spectacles, biometry, and instructions to use study spectacles were done. A follow up visit will be conducted in 3, 6 and 12 months time, in which the latter visit will also be the end of visit. All of which are non-contact and non-invasive to the eyes.

Masking:

Double (Participant, Investigator)

Masking Description:

Subjects (and their parents/guardians) will be masked to the lens assignment. Sibling of subjects must be excluded due to the noticeable differences between the test and control spectacle lenses Only the statistician will be unmasked when comparing the two lenses. The investigator who is responsible for randomization and allocation will also be unmasked. However, the primary outcome variables (spherical equivalent refraction & axial length) will be taken by masked investigators. To facilitate this, the subject will be led into the room(s) containing a biometer without their study spectacles by the unmasked investigator.

Primary Purpose:

Treatment

Official Title:

A Double-masked, Randomized, 2-armed Comparative Study of a Myopia Control Lens (Test Lens) Versus Single Vision Lens (Control Lens).

Actual Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test myopia control lenses A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.	Device: Test myopia control lenses A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.
Other: Single vision lenses A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.	Device: Single vision lenses A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.

Arm

Intervention/Treatment

Experimental: Test myopia control lenses

A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.

Device: Test myopia control lenses

A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.

Other: Single vision lenses

A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.

Device: Single vision lenses

A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.

Outcome Measures

Primary Outcome Measures

Axial Length [12 months]
Change in ocular axial length (mm) measured using Lenstar Optical Biometer.

Secondary Outcome Measures

Spherical Equivalent Refraction [6 months and 12 months]
Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 13 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 8 years and not older than 13 years at time of informed consent and assent.
Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye.
Astigmatism, if present, of not more than 1.50 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 equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status.
History of myopia control intervention
Absence of strabismus by cover test at near or distance wearing correction.
Absence of amblyopia
Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.