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

Alcon Research101 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

101

Conditions

Presbyopia

Interventions

Lehfilcon A multifocal contact lensesDEVICE

Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia

Lotrafilcon B multifocal contact lensesDEVICE

Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia

CLEAR CARE®DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Able to understand and sign an informed consent form that has been approved by an Institutional Review Board. * Willing and able to attend all study visits as required by the protocol. * Willing to stop wearing habitual contact lenses for the duration of the study. * Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included. * Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: * Any eye infection, inflammation, abnormality, or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator. * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator. * History of refractive surgery or planning to have refractive surgery during the study. * Current or history of pathologically dry eye. * Currently pregnant or lactating. * Other protocol-specified exclusion criteria may apply.

Locations (8)

Kindred Optics at Maitland Vision

Maitland, Florida, United States

Vision Health Institute

Orlando, Florida, United States

Kannarr Eye Care LLC

Pittsburg, Kansas, United States

The Eye Doctors, Inc.

Eden Prairie, Minnesota, United States

Outcomes

Primary Outcomes

Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses

Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

Time frame: Day 30, each wear period. A wear period was approximately 30 days.

Data from ClinicalTrials.gov

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