Comparison of Two Multifocal Contact Lenses

NCT ID: NCT01250054

Last Updated: 2012-06-29

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-10-31

Brief Summary

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The purpose of this study is to compare two multifocal contact lenses in presbyopic wearers.

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

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lotrafilcon B / Comfilcon A

Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.

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 (Europe), silicone hydrogel, multifocal contact lens for daily wear use

Comfilcon A /Lotrafilcon B

Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.

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 (Europe), 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 (Europe), 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.
* Sign written Informed Consent
* Spectacle add of +0.50 to +2.50D.
* Best corrected visual acuity of at least 20.30 in both eyes.
* Currently wearing soft contact lenses at least 5 days per week.

Exclusion Criteria

* Eye injury or surgery within twelve weeks of enrollment.
* Currently enrolled in any clinical trial.
* Astigmatism \> 1.00D.
* Strabismus/amblyopia.
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

Other Identifiers

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P-319-C-018

Identifier Type: -

Identifier Source: org_study_id