Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is: Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children? Researchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression. Participants will: * Wear the study spectacles * Visit Essilor R\&D Centre for follow-up sessions

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 11
Healthy Volunteers: f
View:

• Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.

• Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.

• Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.

• Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen).

• Be in good general health, based on his/her and parent's/guardian's knowledge.

• Agree to wear spectacles for \>12 hours/day and at least 6 days/week.

• Willingness and ability to participate in investigation for 2 years and attend scheduled visits.

Locations
Other Locations
Singapore
Essilor R&D Centre Singapore
RECRUITING
Singapore
Contact Information
Primary
Celine Carimalo
carimalc@essilor.com.sg
+65 67134617
Backup
Thomas Boudenne
thomas.boudenne@essilor.com
Time Frame
Start Date: 2025-06-26
Estimated Completion Date: 2027-12
Participants
Target number of participants: 35
Treatments
Experimental: Group A
(Year 1) OD: SVL with passive red-light emission; OS: SVL (Year 2) OD: MCL; OS: MCL with passive red-light emission
Experimental: Group B
(Year 1) OD: SVL; OS: SVL with passive red-light emission (Year 2) OD: MCL with passive red-light emission; OS: MCL
Related Therapeutic Areas
Sponsors
Leads: Essilor International

This content was sourced from clinicaltrials.gov