Evaluation of Deposits on Contact Lenses Worn Daily Wear

NCT ID: NCT00725153

Last Updated: 2012-08-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study was to measure front surface deposits on contact lenses when worn for ten hours.

Detailed Description

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Conditions

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Refractive Error

Keywords

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Contact lens deposits Soft contact lenses Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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PureVision/Acuvue 2

PureVision contact lenses worn first, with Acuvue 2 contact lenses worn second. Both products worn for 10 hours each.

Group Type OTHER

Balafilcon A contact lenses (PureVision)

Intervention Type DEVICE

Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Etafilcon A contact lenses (Acuvue2)

Intervention Type DEVICE

Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Acuvue 2/PureVision

Acuvue 2 contact lenses worn first, with PureVision contact lenses worn second. Both products worn for 10 hours each.

Group Type OTHER

Balafilcon A contact lenses (PureVision)

Intervention Type DEVICE

Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Etafilcon A contact lenses (Acuvue2)

Intervention Type DEVICE

Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Interventions

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Balafilcon A contact lenses (PureVision)

Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Intervention Type DEVICE

Etafilcon A contact lenses (Acuvue2)

Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Intervention Type DEVICE

Other Intervention Names

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PureVision Acuvue2

Eligibility Criteria

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Inclusion Criteria

* 18 years or older.
* Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
* Successfully wearing hydrogel or silicone hydrogel contact lenses prior to enrollment in the study.

Exclusion Criteria

* Evidence or history of keratitis (dendritic keratitis); viral disease of the cornea and/or conjunctiva; acute bacterial disease of the cornea and/or conjunctiva and/or eyelids; infection of the eye; and/or fungal disease of the eye.
* One functional eye or a monofit lens.
* Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis.
* Any slit-lamp finding score of (1) at the Screening Visit as defined in protocol.
* Use of concomitant topical ocular prescription or over-the-counter (OTC) ocular medications.
* History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MS-006

Identifier Type: -

Identifier Source: org_study_id