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

Alcon Research36 enrolled

Overview

The purpose of this study is to obtain on-eye performance data to inform contact lens product development.

Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Refractive Errors

Interventions

Lehfilcon A contact lensesDEVICE

Investigational silicone hydrogel contact lenses

Comfilcon A contact lensesDEVICE

Commercially available silicone hydrogel contact lenses

Multi-purpose disinfection solutionDEVICE

Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Sign Informed Consent document. * Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months. * Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes. * Other protocol-specified inclusion criteria may apply. Exclusion Criteria * Any eye condition or disease or use of medication that contraindicates contact lens wear. * Eye surgery, irregular cornea, eye injury as specified in the protocol. * Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment. * Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear. * Habitually wears Biofinity contact lenses. * Other protocol-specified exclusion criteria may apply.

Locations (3)

Alcon Investigative Site

Maitland, Florida, United States

Alcon Investigative Site

Bloomington, Illinois, United States

Alcon Investigative Site

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

Distance VA (logMAR) With Study Lenses

Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

Time frame: Day 30 after a minimum of 6 hours of wear, each product

Data from ClinicalTrials.gov

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