Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
NCT06850168 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2025-08-07
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
Conditions
- Myopia
Interventions
- DEVICE
-
SVL
Dispensed to one eye in Year 1
- DEVICE
-
SVL with passive red-light emission
Dispensed to the contralateral eye in Year 1.
- DEVICE
-
MCL
Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).
- DEVICE
-
MCL with passive red-light emission
Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).
Sponsors & Collaborators
-
Essilor International
lead INDUSTRY
Principal Investigators
-
Andrew Tan · Essilor R&D Centre Singapore
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-26
- Primary Completion
- 2027-10-31
- Completion
- 2027-12-31
Countries
- Singapore
Study Locations
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