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

Alcon Research66 enrolled

Overview

The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Myopia

Interventions

Lehfilcon A contact lensesDEVICE

Investigational silicone hydrogel contact lenses

Comfilcon A contact lensesDEVICE

Commercially available silicone hydrogel contact lenses

CLEAR CAREDEVICE

Hydrogen peroxide-based cleaning and disinfecting solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Able to understand and sign an approved Informed Consent form; * Willing and able to attend all scheduled study visits as required by the protocol; * Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day; * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * Current or prior Biofinity contact lens wearer in the past 3 months; * Monovision contact lens wearer; * Other protocol-defined exclusion criteria may apply.

Locations (5)

Alcon Investigative Site

Maitland, Florida, United States

Alcon Investigative Site

Bloomington, Illinois, United States

Alcon Investigative Site

Pittsburg, Kansas, United States

Alcon Investigative Site

Shawnee Mission, Kansas, United States

Outcomes

Primary Outcomes

Mean Distance Visual Acuity (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). On Day 30, VA was assessed after 6-8 hours of wear. 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 1, Day 30 after 6-8 hours of wear, each product

Data from ClinicalTrials.gov

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