Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens

Alcon Research158 enrolled

Overview

The purpose of this clinical study is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Subjects will be expected to attend 4 office visits: Screening/Baseline/Dispense, Week 1 Follow-up, Month 1 Follow-up, and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3-4 months in this daily wear clinical study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

158

Conditions

Refractive Errors

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 contact lens cleaning and disinfecting solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day; * Manifest cylinder equal to or less than 0.75 diopter (D) in each eye; * Best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye; * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; * Habitually wearing Biofinity lenses; * Monovision or multifocal contact lens wearers; * Other protocol-defined exclusion criteria may apply.

Locations (14)

Alcon Investigative Site

Los Angeles, California, United States

Alcon Investigative Site

Novato, California, United States

Alcon Investigative Site

Oakland, California, United States

Outcomes

Primary Outcomes

Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up

Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.

Time frame: Week 1 Follow-Up

Secondary Outcomes

Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye at Week 1 Follow-Up

Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight. Subjects achieving at least 20/20 Snellen in each eye, left and right, contributed to the analysis.

Time frame: Week 1 Follow-Up

Data from ClinicalTrials.gov

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