Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

N/ACompletedNCT03920280

Alcon Research120 enrolled

Overview

The purpose of this clinical study is to demonstrate 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 randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Refractive Errors

Interventions

LID015385 contact lensesDEVICE

Investigational silicone hydrogel contact lenses

Comfilcon A soft contact lensesDEVICE

Commercially available silicone hydrogel contact lenses

CLEAR CAREDEVICE

Hydrogen peroxide-based cleaning and disinfecting system

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 ≤ 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. * Monovision contact lens wearers. * Habitually wearing Biofinity® lenses. * Other protocol-specified exclusion criteria may apply.

Locations (8)

Alcon Investigator 6565

Maitland, Florida, United States

Alcon Investigator 6355

Orlando, Florida, United States

Alcon Investigator 6291

Pensacola, Florida, United States

Alcon Investigator 3950

Bloomington, Illinois, United States

Outcomes

Primary Outcomes

Distance Visual Acuity (VA) 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 lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.

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

Distance Visual Acuity (VA) With Study Lenses - Discontinued 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 the logarithm minimum angle of resolution (logMAR) scale. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.

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

Data from ClinicalTrials.gov

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