NCT05765227

Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.

Detailed description

Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.

Conditions

• Refractive Ametropia

Interventions

Type	Name	Description
DEVICE	Lehfilcon A multifocal contact lenses	Investigational silicone hydrogel multifocal contact lenses
DEVICE	Lotrafilcon B multifocal contact lenses	Commercially available silicone hydrogel multifocal contact lenses
DEVICE	Hydrogen peroxide-based cleaning and disinfection system	Commercially available cleaning and disinfection system for silicone hydrogel contact lenses

Timeline

• Start date: 2023-03-08
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2023-03-13
• Last updated: 2024-04-16
• Results posted: 2024-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study