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Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

NCT ID: NCT01035905

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

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nelfilcon A

Nelfilcon A contact lens

Group Type EXPERIMENTAL

Nelfilcon A contact lens

Intervention Type DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Narafilcon A

Narafilcon A contact lens

Group Type ACTIVE_COMPARATOR

Narafilcon A contact lens

Intervention Type DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Interventions

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Nelfilcon A contact lens

Daily disposable contact lens worn in a daily wear, daily disposable mode

Intervention Type DEVICE

Narafilcon A contact lens

Daily disposable contact lens worn in a daily wear, daily disposable mode

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.
* Habitually wear lenses for at least 8 hours per day and 4 days per week.
* Report 2 or more qualifying symptoms with current contact lenses.
* Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.

Exclusion Criteria

* Eye injury or surgery within twelve weeks immediately prior to enrollment.
* Currently enrolled in any clinical trial.
* Any use of ocular medications, exclusive of contact lens rewetting drops.
* History of corneal or refractive surgery.
* Cylinder correction greater than 1.00 D
* Current monovision contact lens wearers.
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

Countries

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United States

Other Identifiers

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P-337-C-030

Identifier Type: -

Identifier Source: org_study_id