NCT06165627

Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the clinical performance of TOTAL30 for Astigmatism (T30fA) soft contact lenses with Biofinity Toric soft contact lenses.

Detailed description

Subjects will be expected to attend 5 office visits and will be dispensed study lenses (per randomization sequence) for 30-day duration of bilateral wear with each study lens (approximately 60 days of lens wear). The total duration of the subject's participation in the study will be approximately 74 days.

Conditions

• Ametropia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Lehfilcon A toric contact lenses	Commercially available soft contact lenses worn as indicated
DEVICE	Comfilcon A toric contact lenses	Commercially available soft contact lenses) worn as indicated
DEVICE	CLEAR CARE	Commercially available hydrogen peroxide-based solution for daily cleaning and disinfection of contact lenses used as indicated

Timeline

• Start date: 2024-01-23
• Primary completion: 2024-05-12
• Completion: 2024-05-12
• First posted: 2023-12-11
• Last updated: 2025-05-29
• Results posted: 2025-05-29

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study