NCT05243836

S.T.O.P.® Technology Contact Lenses Versus Dual-focus Contact Lenses for Slowing Down Myopia Progression in Children

Contact Lenses Utilising S.T.O.P.® Technology Versus Dual-focus Contact Lenses for Slowing Down Myopia Progression in Children: A Three-year Prospective, Multi-centre, Controlled, Masked, Randomised, Non Inferiority Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 441 (estimated)
• Sponsor: nthalmic Pty Ltd · Network
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

To compare the rate of myopia progression of contact lenses utilising S.T.O.P.® technology against MiSight® contact lenses.

Detailed description

Myopic children (8-14 years of age) will be randomly allocated to wear one of 3 contact lens options (MiSight®, S.T.O.P.®- F2 or S.T.O.P.®- DT) bilaterally on a daily wear basis. The overall trial duration, including follow-up period, is expected to be approximately 48 months. Each participant's duration is expected to be approximately 36 months. The visits are Baseline / Fit, Dispensing, 1 week, 1 month, 6 months then visits every 6 months after. All procedures performed at these visits are standard, non invasive clinical tests.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	S.T.O.P® F2	Ocufilcon D, 55% water
DEVICE	S.T.O.P® DT	Ocufilcon D, 55% water
DEVICE	MiSight®	Omafilcon A (60% water)

Timeline

• Start date: 2023-08-04
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2022-02-17
• Last updated: 2026-03-05

Locations

7 sites across 3 countries: China, India, Spain