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Four Week Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

NCT ID: NCT01300767

Last Updated: 2012-07-10

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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-04-30

Brief Summary

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The purpose of this study is to compare the performance of two commercially marketed contact lenses when worn for up to 4 weeks in a daily wear modality.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lotrafilcon B

Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality.

Group Type EXPERIMENTAL

Lotrafilcon B contact lens (AIR OPTIX® AQUA)

Intervention Type DEVICE

Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.

Contact lens solution (Clear Care®)

Intervention Type DEVICE

Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.

Balafilcon A

Balafilcon A commercially marketed contact lens randomly assigned to one eye, with lotrafilcon B commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality.

Group Type ACTIVE_COMPARATOR

Balafilcon A contact lens (PureVision® 2)

Intervention Type DEVICE

Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.

Contact lens solution (Clear Care®)

Intervention Type DEVICE

Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.

Interventions

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Lotrafilcon B contact lens (AIR OPTIX® AQUA)

Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.

Intervention Type DEVICE

Balafilcon A contact lens (PureVision® 2)

Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.

Intervention Type DEVICE

Contact lens solution (Clear Care®)

Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.

Intervention Type DEVICE

Other Intervention Names

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AIR OPTIX® AQUA PureVision® 2 Clear Care®

Eligibility Criteria

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Inclusion Criteria

* Habitual spherical soft contact lens wearer who wears a contact lens brand with a recommended replacement schedule of 2 weeks or greater.
* Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses.
* Willing and able to wear spherical contact lenses within the available range of powers.
* Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly.

Exclusion Criteria

* Eye injury or surgery within twelve weeks prior to enrollment.
* Currently enrolled in any clinical trial.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Astigmatism of 1.00D or more.
* Currently wearing contact lenses in a daily disposable modality.
* Currently wearing AIR OPTIX AQUA or PureVision 2 contact lenses
* Currently sleeping overnight in contact lenses on an occasional or extended wear basis.
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-336-C-019

Identifier Type: -

Identifier Source: org_study_id