Evaluation of a New Daily Disposable Multifocal Contact Lens Design

N/ACompletedNCT01951573

Alcon Research36 enrolled

Overview

The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Presbyopia Hyperopia Refractive Error

Interventions

Delefilcon A multifocal contact lensesDEVICE

Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use

Lotrafilcon B multifocal contact lensesDEVICE

Silicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with normal eyes who are not using any ocular medication. * Must sign the Informed Consent document. * Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)). * Manifest cylinder less than or equal to 0.75D. * Best corrected distance VA greater than or equal to 20/25 in each eye. * Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week. * Presbyopic with a spectacle addition (ADD) \>0.50D and \<2.75D. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Any ocular disease, inflammation, or abnormality that contraindicates CL wear. * Any use of systemic or ocular medications for which CL wear could be contraindicated. * History of herpetic keratitis. * History of refractive surgery or irregular cornea. * A clinically significant dry eye that precludes CL wear. * Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days. * Monocular (only 1 eye with functional vision). * History of intolerance or hypersensitivity to any component of the test articles. * Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near

Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.

Time frame: Dispense (Day 1), Hour 9

Secondary Outcomes

HC/HI Binocular VA at Distance

Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.

Time frame: Dispense (Day 1), Hour 9

Over-refraction (OR) Monocular at Distance

OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.

Time frame: Dispense (Day 1), Hour 9

Data from ClinicalTrials.gov

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