NCT05338333

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.

Detailed description

Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Lehfilcon A multifocal contact lenses	Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia
DEVICE	Lotrafilcon B multifocal contact lenses	Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia
DEVICE	CLEAR CARE®	Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Timeline

• Start date: 2022-05-27
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2022-04-21
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study