NCT06461455

Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.

Detailed description

Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 30 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 5 office visits. The total duration of study participation is approximately 66 days.

Conditions

• Presbyopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Lehfilcon A multifocal for astigmatism contact lenses	Investigational multifocal contact lenses for astigmatism
DEVICE	Samfilcon A multifocal for astigmatism contact lenses	Commercially available multifocal contact lenses for astigmatism
DEVICE	CLEAR CARE® Cleaning & Disinfecting Solution	Hydrogen peroxide-based contact lens cleaning and disinfection system
DEVICE	Lehfilcon A multifocal for astigmatism contact lenses	Investigational multifocal contact lenses for astigmatism
DEVICE	CLEAR CARE® Cleaning & Disinfecting Solution	Hydrogen peroxide-based contact lens cleaning and disinfection system

Timeline

• Start date: 2024-07-26
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-06-17
• Last updated: 2025-12-24
• Results posted: 2025-12-24

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study