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

NCT05534022 | Active Not Recruiting

• 1 other identifier: WS10273
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

Refractive errors; Eye diseases

Outcome Measures

Primary Outcomes (1)

• Axial Length

  Change in ocular axial length (mm)

  12 months and 24 months

Secondary Outcomes (2)

• Axial Length

  6 months and 18 months

• Spherical Equivalent Refraction

  6 months, 12 months, 18 months and 24 months

Study Arms (1)

Test myopia control lenses (BSL)

EXPERIMENTAL

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

Device: Test myopia control lenses (BSL)

Interventions

Test myopia control lenses (BSL) DEVICE

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

Test myopia control lenses (BSL)

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Essilor International: lead

Study Sites (1)

Essilor R&D Centre Singapore

Singapore, 339346, Singapore

Location

Related Publications (1)

• 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.

  PMID: 33811039 BACKGROUND

MeSH Terms

Conditions

Myopia; Refractive Errors; Eye Diseases

Study Officials

• Wee Sing Ong

  Essilor R&D Centre Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: September 26, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

SG (1)