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Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

Primary Purpose

Myopia, Progressive, Myopia

Status

Active

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Test myopia control lenses

Single vision lenses

About this trial

This is an interventional treatment trial for Myopia, Progressive focused on measuring refractive error, eye disease, short-sightedness, children myopia, myopia progression

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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.

Exclusion Criteria

Vulnerability of subject
Participation in any clinical study within 30 days of the Baseline visit.
Sibling of existing participant of this study

Sites / Locations

Essilor R&D Centre Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Test myopia control lenses

Single vision lenses

Arm Description

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

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

Outcomes

Primary Outcome Measures

Axial Length

Change in ocular axial length (mm) measured using Lenstar Optical Biometer.

Secondary Outcome Measures

Spherical Equivalent Refraction

Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction.

Axial Length

Change in ocular axial length (mm) measured using Lenstar Optical Biometer.

Carry-over Effect

Change in ocular axial length (mm) measured using Lenstar Optical Biometer after switching to STELLEST™ lenses

Full Information

NCT ID

NCT05331378

First Posted

April 8, 2022

Last Updated

September 5, 2023

Sponsor

Essilor International

1. Study Identification

Unique Protocol Identification Number

NCT05331378

Brief Title

Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 25, 2022 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Essilor International

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia, Progressive, Myopia

Keywords

refractive error, eye disease, short-sightedness, children myopia, myopia progression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a randomized, controlled, 2-armed, double-masked, monocenter, clinical trial, which consists of 6 visits across 1 year. The test myopia control lens will be compared with a single vision control 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 8-13 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

ParticipantInvestigator

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.

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test myopia control lenses

Arm Type

Experimental

Arm Description

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

Arm Title

Single vision lenses

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Test myopia control lenses

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Single vision lenses

Intervention Description

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

Primary Outcome Measure Information:

Title

Axial Length

Description

Change in ocular axial length (mm) measured using Lenstar Optical Biometer.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Spherical Equivalent Refraction

Description

Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction.

Time Frame

6 months and 12 months

Title

Axial Length

Description

Change in ocular axial length (mm) measured using Lenstar Optical Biometer.

Time Frame

6 months

Title

Carry-over Effect

Description

Change in ocular axial length (mm) measured using Lenstar Optical Biometer after switching to STELLEST™ lenses

Time Frame

18 months and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. Exclusion Criteria Vulnerability of subject Participation in any clinical study within 30 days of the Baseline visit. Sibling of existing participant of this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Tan

Organizational Affiliation

Essilor R&D Centre Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

Essilor R&D Centre Singapore

City

Singapore

ZIP/Postal Code

339346

Country

Singapore

12. IPD Sharing Statement

Citations:

PubMed Identifier

33811039

Citation

Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.

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Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

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