NCT05766787

The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

Detailed description

In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.

Conditions

• Refractive Ametropia

Interventions

Type	Name	Description
DEVICE	Serafilcon A contact lenses	Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
DEVICE	Senofilcon A contact lenses	Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
DEVICE	CLEAR CARE	Hydrogen peroxide based contact lens cleaning and disinfecting solution

Timeline

• Start date: 2023-03-29
• Primary completion: 2023-06-02
• Completion: 2023-06-02
• First posted: 2023-03-13
• Last updated: 2024-06-13
• Results posted: 2024-06-13

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study