Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses

Alcon Research18 enrolled

Overview

The purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.

Subjects will attend 3 study visits with a planned individual duration of participation of up to 10 days.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Refractive Errors Presbyopia Astigmatism

Interventions

Lehfilcon A multifocal toric contact lensesDEVICE

Investigational silicone hydrogel contact lenses

Samfilcon A multifocal toric contact lensesDEVICE

Commercially available silicone hydrogel contact lenses

CLEAR CAREDEVICE

Hydrogen peroxide based contact lens cleaning and disinfecting solution

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Requires ADD (additional power for near vision); * Currently wears multifocal soft contact lenses in both eyes during the past 3 months; * Manifest cylinder power between -0.75 diopter (D) and -1.00 D; * Best Corrected Visual Acuity (BCVA) of logMAR 0.10 (Snellen 20/25) or better in each eye. * Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: * Any anterior segment 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; * Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear; * Monovision contact lens wear. * Other protocol-specified exclusion criteria may apply.

Locations (1)

Johns Creek Research Clinic

Johns Creek, Georgia, United States

Outcomes

Primary Outcomes

Mean Distance Visual Acuity (VA) With Study Lenses

Visual Acuity (VA) was assessed binocularly (both eyes together) with study lenses in place at a distance of 4 meters using letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR), where 0.0 logMAR equates to 20/20 Snellen (normal distance eyesight). A lower number indicates better visual acuity. No hypothesis testing is pre-specified for this endpoint.

Time frame: Day 2, each wear period. A wear period was approximately 2 days.

Data from ClinicalTrials.gov

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