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

NCT ID: NCT01371539

Last Updated: 2012-08-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-08-31

Brief Summary

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

Detailed Description

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Conditions

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Myopia Presbyopia

Keywords

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Myopia Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lotrafilcon B / Comfilcon A

Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.

Group Type OTHER

Lotrafilcon B contact lens

Intervention Type DEVICE

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

Comfilcon A contact lens

Intervention Type DEVICE

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

Comfilcon A / Lotrafilcon B

Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.

Group Type OTHER

Lotrafilcon B contact lens

Intervention Type DEVICE

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

Comfilcon A contact lens

Intervention Type DEVICE

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

Interventions

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Lotrafilcon B contact lens

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

Intervention Type DEVICE

Comfilcon A contact lens

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

Intervention Type DEVICE

Other Intervention Names

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AIR OPTIX AQUA MULTIFOCAL Biofinity Multifocal

Eligibility Criteria

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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.

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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stacie Cummings, O.D.

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

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P-319-C-021

Identifier Type: -

Identifier Source: org_study_id