Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

Alcon Research60 enrolled

Overview

The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.

The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Myopia Ametropia

Interventions

Verofilcon A contact lensesDEVICE

Commercially available silicone hydrogel contact lenses for daily disposable wear

Kalifilcon A contact lensesDEVICE

Commercially available silicone hydrogel contact lenses for daily disposable wear

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board. * Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * Current/previous PRECISION1 or INFUSE contact lens wearer. * Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator. * Routinely sleeps in contact lenses. * Other protocol-defined exclusion criteria may apply.

Locations (4)

Alcon Investigator 6565

Maitland, Florida, United States

Alcon Investigator 6355

Orlando, Florida, United States

Alcon Investigator 6583

Eden Prairie, Minnesota, United States

Alcon Investigator 6313

Powell, Ohio, United States

Outcomes

Primary Outcomes

Distance VA (logMAR) With Study Lenses

Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No inferential testing was pre-specified for this endpoint.

Time frame: Day 8 (-0/+3 days), each study lens type

Data from ClinicalTrials.gov

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