Clincosm LogoSign in Get a demo

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

Sponsor
Essilor International (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05534022
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
14
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Test myopia control lenses (BSL)
 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 (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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a mono-centre, prospective, one-arm, unmasked clinical trial, which consists of 6 visits, across 12 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 and 12 months time, where 12 months is the end of study. All of the eye examinations and assessments are non-contact and non-invasive to the eyes.This is a mono-centre, prospective, one-arm, unmasked clinical trial, which consists of 6 visits, across 12 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 and 12 months time, where 12 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)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression - Open Clinical Trial
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test myopia control lenses (BSL)

A pair of myopia control spectacle lenses (test lenses) will be given to subjects to wear for 12 months

Device: Test myopia control lenses (BSL)
A pair of myopia control spectacle lenses (test lenses) will be given to subjects to wear for 12 months

Outcome Measures

Primary Outcome Measures

  1. Axial Length [12 months]

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

Secondary Outcome Measures

  1. 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.

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Essilor R&D Centre Singapore Singapore Singapore 339346

Sponsors and Collaborators

  • Essilor International

Investigators

  • Principal Investigator: Wee Sing Ong, Essilor R&D Centre Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Essilor International
ClinicalTrials.gov Identifier:
NCT05534022
Other Study ID Numbers:
  • WS10273
First Posted:
Sep 9, 2022
Last Update Posted:
Sep 13, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Essilor International
Refractive errors
Eye diseases
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Sep 13, 2022