Comparison of Two New Silicone Hydrogel Multifocal Products

N/ACompletedNCT00823615

CIBA VISION40 enrolled

Overview

The purpose of this trial is to compare the performance of two multifocal contact lenses.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Presbyopia

Interventions

Lotrafilcon B multifocal contact lensDEVICE

Silicone hydrogel, soft, multifocal contact lens for daily wear use

Senofilcon A multifocal contact lensDEVICE

Silicone hydrogel, soft, 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 * Best-corrected visual acuity of at least 20/40 in each eye. * Spectacle add between +0.75D and +1.50D (inclusive). * Able to be fit in available study sphere powers (-0.50 to -5.50D). * Currently wearing soft contact lenses at least 5 days a week. * Other protocol inclusion/exclusion criteria may apply. Exclusion Criteria: * Requires concurrent ocular medication. * Eye injury or surgery within twelve weeks immediately prior to enrollment. * Currently enrolled in an ophthalmic Clinical Trial. * Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions. * Previous refractive surgery. * Astigmatism \> 1.00D. * Currently wearing ACUVUE OASYS for PRESBYOPIA. * Other protocol inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

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

Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.

Time frame: After 1 week of wear

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

Tested while reading charts at 40 cm with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.

Time frame: After 1 week of wear

Data from ClinicalTrials.gov

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