Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

Alcon Research119 enrolled

Overview

The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.

Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

119

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 system for cleaning and disinfecting silicone hydrogel contact lenses

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. * Other protocol-specified 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 contact lenses. * Monovision contact lens wearers. * Other protocol-specified exclusion criteria may apply.

Locations (8)

Alcon Investigative Site

Longwood, Florida, United States

Alcon Investigative Site

Maitland, Florida, United States

Alcon Investigative Site

Orlando, Florida, United States

Alcon Investigative Site

Bloomington, Illinois, United States

Outcomes

Primary Outcomes

Distance VA (logMAR) With Study Lenses - Completed Eyes

Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

Time frame: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)

Distance VA (logMAR) With Study Lenses - Discontinued Eyes

Time frame: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up

Data from ClinicalTrials.gov

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