NCT06232590

Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: CooperVision International Limited (CVIL) · Industry
• Sex: All
• Age: 42 Years
• Healthy volunteers: Not accepted

Summary

To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.

Detailed description

This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 4-6 weeks: the lens prescription of each lens type was optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) wear period.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Control Lens (comfilcon A)	Multifocal monthly replacement contact lens for 1 month
DEVICE	Test Lens (lehfilcon A)	Multifocal monthly replacement contact lens for 1 month

Timeline

• Start date: 2024-02-23
• Primary completion: 2024-07-09
• Completion: 2024-07-09
• First posted: 2024-01-31
• Last updated: 2025-02-12
• Results posted: 2025-02-12

Locations

5 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study