Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression (DAL)

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Test myopia control lenses (DAL)

About this trial

This is an interventional treatment trial for Myopia focused on measuring Refractive error, Eye disease

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. 8 to 13 years old 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 SingaporeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Test myopia control lenses (DAL)

Arm Description

A pair of myopia control spectacle lenses (test lenses) will be given to subjects 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

Full Information

NCT ID

NCT05840185

First Posted

April 21, 2023

Last Updated

September 12, 2023

Sponsor

Essilor International

1. Study Identification

Unique Protocol Identification Number

NCT05840185

Brief Title

Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression (DAL)

Official Title

Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression - DAL

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 10, 2023 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 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

Data Monitoring Committee

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 error, Eye disease

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 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)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Test myopia control lenses (DAL)

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Test myopia control lenses (DAL)

Intervention Description

A pair of myopia control spectacle lenses (test lenses) will be given to subjects 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

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. 8 to 13 years old 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Celine Carimalo

Phone

67134617

Email

carimalc@essilor.com.sg

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Boudenne

Email

thomas.boudenne@essilor.com

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Boudenne

Email

thomas.boudenne@essilor.com

First Name & Middle Initial & Last Name & Degree

Andrew Tan

First Name & Middle Initial & Last Name & Degree

Farah Salleh

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

background

Myopia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial