NCT04980456

Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.

Detailed description

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Lehfilcon A contact lenses	Investigational silicone hydrogel contact lenses
DEVICE	Comfilcon A contact lenses	Commercially available silicone hydrogel contact lenses
DEVICE	CLEAR CARE	Hydrogen peroxide-based cleaning and disinfecting solution

Timeline

• Start date: 2021-08-05
• Primary completion: 2021-11-20
• Completion: 2021-11-20
• First posted: 2021-07-28
• Last updated: 2023-01-06
• Results posted: 2023-01-06

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study