Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia

NCT07839091 | Not Yet Recruiting

• 1 other identifier: WS10528
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years. The main question being studied is: Is the new myopia control spectacle lens more effective than a standard single vision spectacle lens in slowing myopia progression? In this study, participants will wear a myopia control spectacle lens in one eye and a standard single vision spectacle lens in the other eye for the first 6 months. The lens assignment will then be switched between eyes for the remaining 6 months. Researchers will compare changes in eye axial length and refractive error between the two lens types. Participants will:

• Wear the study spectacles for 12 months.
• Attend scheduled follow-up visits at the Essilor R\&D Centre, Singapore.

Conditions

Myopia; Myopia Progression

Keywords

refractive error; myopia control; axial length

Outcome Measures

Primary Outcomes (1)

• Change in Eye Axial Length

  From baseline to 6 months

Secondary Outcomes (3)

• Change in Eye Axial Length

  From 6 months to 12 months

• Change in Eye Non-Cycloplegic Spherical Equivalent Refraction

  From baseline to 6 months

• Change in Eye Non-Cycloplegic Spherical Equivalent Refraction

  From 6 months to 12 months

Study Arms (2)

OD: SVL; OS: MCL then OD: MCL; OS: SVL

EXPERIMENTAL

Participants will wear the investigational myopia control spectacle lens in the left eye and a standard single vision spectacle lens in the right eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months.

Device: Investigational Myopia Control Spectacle Lens; Device: Single Vision Spectacle Lens

OD: MCL; OS: SVL then OD: SVL; OS: MCL

EXPERIMENTAL

Participants will wear the investigational myopia control spectacle lens in the right eye and a standard single vision spectacle lens in the left eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months.

Device: Investigational Myopia Control Spectacle Lens; Device: Single Vision Spectacle Lens

Interventions

Single Vision Spectacle Lens DEVICE

A standard spectacle lens used to correct refractive error without a specific myopia control feature

OD: MCL; OS: SVL then OD: SVL; OS: MCL; OD: SVL; OS: MCL then OD: MCL; OS: SVL

Investigational Myopia Control Spectacle Lens DEVICE

A spectacle lens designed to help slow the progression of myopia in children

OD: MCL; OS: SVL then OD: SVL; OS: MCL; OD: SVL; OS: MCL then OD: MCL; OS: SVL

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Volunteer participant with the willingness and ability to comply with all scheduled study visits.
• Informed consent of parent/guardian and assent of participant.
• Age equal to or greater than 6 years and less than 11 years (before 11th birthday) at the time of consent.
• Spherical equivalent refraction (SER) equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D.
• Difference in SER (anisometropia) between two eyes should not exceed 1.00 D.
• Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR under high contrast in each eye.
• Be in good general health, based on the participant and the parent's/guardian's knowledge.
• Agree to wear the study spectacles for 12 hours per day and 7 days per week.
• Agree not to be involved in other myopia control treatments.

You may not qualify if:

• History of Atropine, Orthokeratology, Myopia Control Contact Lens, or Red Light treatment.
• Strabismus by cover test at near or distance wearing correction.
• History and presence of amblyopia.
• Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
• Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
• History of ocular injury or surgery.
• Participation in any clinical study within 30 days of the Baseline visit.
• Current or anticipated use of growth hormones.
• Study participants deemed inappropriate for the study by the investigator.
• The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.

Sponsors & Collaborators

• Essilor International: lead

Study Sites (1)

Essilor R&D Centre Singapore

Singapore, Singapore

Location

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Andrew Tan

  Essilor R&D Centre Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celine Carimalo

CONTACT

67134617; carimalc@essilor.com.sg

Thomas Boudenne

CONTACT

thomas.boudenne@essilor.com

Study Design

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

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)