A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-03-31

Brief Summary

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The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.

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Detailed Description

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Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LD118033 contact lens

Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.

Group Type EXPERIMENTAL

LD118033 contact lens

Intervention Type DEVICE

Multifocal contact lens worn on a daily wear basis for 1 week

PureVision multifocal contact lens

PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.

Group Type ACTIVE_COMPARATOR

PureVision multifocal contact lens

Intervention Type DEVICE

PureVision multifocal contact lens worn on a daily wear basis for 1 week.

Interventions

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LD118033 contact lens

Multifocal contact lens worn on a daily wear basis for 1 week

Intervention Type DEVICE

PureVision multifocal contact lens

PureVision multifocal contact lens worn on a daily wear basis for 1 week.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have physiologically normal anterior segments.
* Be adapted wearers of soft contact lenses and wear a lens in each eye.
* Be presbyopic and require near add correction in each eye.
* Have no active ocular disease or allergic conjunctivitis.
* Must not be using any topical ocular medications.

Exclusion Criteria

* Any Grade 2 or greater finding during the slit lamp examination.
* Any scar or neovascularization within the central 4mm of the cornea.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Allergic to any component in the study products.
* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* An active ocular disease, any corneal infiltrative response or are using any ocular medications.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No