NCT05211739

Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.

Detailed description

Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.

Conditions

• Refractive Errors
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Lehfilcon A toric contact lenses	FDA-cleared silicone hydrogel toric contact lenses used as indicated
DEVICE	Comfilcon A toric contact lenses	Commercially available silicone hydrogel toric contact lenses used as indicated
DEVICE	CLEAR CARE	Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Timeline

• Start date: 2022-02-15
• Primary completion: 2022-06-23
• Completion: 2022-06-23
• First posted: 2022-01-27
• Last updated: 2023-06-27
• Results posted: 2023-06-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study