Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

CIBA VISION109 enrolled

Overview

The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

109

Conditions

Myopia Presbyopia

Interventions

Lotrafilcon B contact lensDEVICE

Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.

Comfilcon A contact lensDEVICE

Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 35 years of age. * Spectacle add of +0.50 to +2.50 diopters (inclusive). * Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day. * Able to be fit in both eyes with soft multifocal lenses in available powers. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Eye injury or surgery within 12 weeks of enrollment in trial. * Currently enrolled in any clinical trial. * Astigmatism of 1.00 diopter or more. * Currently wearing excluded brands of multifocal lenses, as specified by protocol. * Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity

The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.

Time frame: 1 week

Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity

The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.

Time frame: 1 week

Data from ClinicalTrials.gov

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