Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers

NCT ID: NCT01233076

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nelfilcon A / Narafilcon B

Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.

Group Type OTHER

Nelfilcon A contact lens

Intervention Type DEVICE

Commercially marketed, spherical contact lens for daily wear, daily disposable use

Narafilcon B contact lens

Intervention Type DEVICE

Commercially marketed (US), spherical contact lens for daily wear, daily disposable use

Narafilcon B / Nelfilcon A

Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.

Group Type OTHER

Nelfilcon A contact lens

Intervention Type DEVICE

Commercially marketed, spherical contact lens for daily wear, daily disposable use

Narafilcon B contact lens

Intervention Type DEVICE

Commercially marketed (US), spherical contact lens for daily wear, daily disposable use

Interventions

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Nelfilcon A contact lens

Commercially marketed, spherical contact lens for daily wear, daily disposable use

Intervention Type DEVICE

Narafilcon B contact lens

Commercially marketed (US), spherical contact lens for daily wear, daily disposable use

Intervention Type DEVICE

Other Intervention Names

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DAILIES AquaComfort Plus 1-DAY ACUVUE TruEye

Eligibility Criteria

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Inclusion Criteria

* Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye.
* Able to wear study lenses in the available powers from -1.00D to -6.00D.

Exclusion Criteria

* Eye injury within twelve weeks of enrollment.
* History of corneal or refractive surgery.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses.
* Monovision correction during the study.
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-337-C-034

Identifier Type: -

Identifier Source: org_study_id