Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens

Alcon Research18 enrolled

Overview

The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.

Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Refractive Ametropia

Interventions

Lehfilcon A multifocal contact lensesDEVICE

Investigational silicone hydrogel multifocal contact lenses

Lotrafilcon B multifocal contact lensesDEVICE

Commercially available silicone hydrogel multifocal contact lenses

Hydrogen peroxide-based cleaning and disinfection systemDEVICE

Commercially available cleaning and disinfection system for silicone hydrogel contact lenses

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB); * Willing to stop wearing habitual contact lenses for the duration of study participation; * Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator; * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; * History of refractive surgery, or plan to have refractive surgery during the study; * Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator; * Monovision contact lens wear; * Other protocol-defined exclusion criteria may apply.

Locations (1)

Johns Creek Research Clinic

Johns Creek, Georgia, United States

Outcomes

Primary Outcomes

Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)

VA was assessed binocularly (both eyes together) using a letter chart and measured in 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 hypothesis testing was prespecified for this endpoint.

Time frame: Day 2, each study lens type worn during the corresponding crossover period

Data from ClinicalTrials.gov

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