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Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression.

Primary Purpose

Myopia

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Test myopia control lenses (BSL)
Sponsored by
Essilor International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Refractive errors, Eye diseases

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.
  • 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
  • History of myopia control intervention
  • Participation in any clinical study within 30 days of the Baseline visit.

Sites / Locations

  • Essilor R&D Centre Singapore

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test myopia control lenses (BSL)

Arm Description

Myopia control spectacle lenses (test lenses) will be given to subjects throughout the 24 months trial.

Outcomes

Primary Outcome Measures

Axial Length
Change in ocular axial length (mm)

Secondary Outcome Measures

Axial Length
Change in ocular axial length (mm)
Spherical Equivalent Refraction
Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction.

Full Information

First Posted
September 6, 2022
Last Updated
September 29, 2023
Sponsor
Essilor International
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1. Study Identification

Unique Protocol Identification Number
NCT05534022
Brief Title
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression.
Official Title
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression - Open Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a mono-centre, prospective, one-arm, unmask clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation compared to a single vision spectacle lens from the historical control group of another clinical trial NCT05331378. A total of 40 children will be recruited.
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 (Bao et al. 2022). A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy. This open clinical trial 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 (40 subjects) at the time of commencing treatment. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuities will also be compared between test lenses and control lenses of the historical control group 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
Keywords
Refractive errors, Eye diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a mono-centre, prospective, one-arm, unmasked clinical trial, which consists of 9 visits, across 24 months. The objective of this clinical trial is to compare the test myopia control spectacle lens to the single vision control spectacle lens from the previous clinical trial, otherwise termed as historical control group. After obtaining informed consent and assent, a comprehensive eye examination will be conducted during the screening visit on all 40 myopic children between the age of 8 to 13 years old. Eligible children will return in a separate visit (baseline visit) to collect the study spectacles and the assessment of study spectacles, biometry and instructions to use study spectacles are established in the same visit. A follow up visit will be conducted in 3, 6, 12, 18 and 24 months time, where 24 months is the end of study. All of the eye examinations and assessments are non-contact and non-invasive to the eyes.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test myopia control lenses (BSL)
Arm Type
Experimental
Arm Description
Myopia control spectacle lenses (test lenses) will be given to subjects throughout the 24 months trial.
Intervention Type
Device
Intervention Name(s)
Test myopia control lenses (BSL)
Intervention Description
Myopia control spectacle lenses (test lenses) will be given to subjects throughout the 24 months trial.
Primary Outcome Measure Information:
Title
Axial Length
Description
Change in ocular axial length (mm)
Time Frame
12 months and 24 months
Secondary Outcome Measure Information:
Title
Axial Length
Description
Change in ocular axial length (mm)
Time Frame
6 months and 18 months
Title
Spherical Equivalent Refraction
Description
Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction.
Time Frame
6 months, 12 months, 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
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. 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 History of myopia control intervention Participation in any clinical study within 30 days of the Baseline visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wee Sing Ong
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.
Results Reference
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Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression.

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