Evaluation of Deposits on Contact Lenses Worn Extended Wear

NCT ID: NCT00725530

Last Updated: 2012-08-22

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-10-31

Brief Summary

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The purpose of this study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days.

Detailed Description

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Conditions

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Myopia

Keywords

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Lens deposits Soft contact lens wearers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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balafilcon A / etafilcon A

Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.

Group Type ACTIVE_COMPARATOR

balafilcon A contact lens (PureVision)

Intervention Type DEVICE

Commercially marketed, silicone hydrogel contact lens

etafilcon A contact lens (Acuvue2)

Intervention Type DEVICE

Commercially marketed, hydrogel contact lens

etafilcon A / balafilcon A

Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.

Group Type ACTIVE_COMPARATOR

balafilcon A contact lens (PureVision)

Intervention Type DEVICE

Commercially marketed, silicone hydrogel contact lens

etafilcon A contact lens (Acuvue2)

Intervention Type DEVICE

Commercially marketed, hydrogel contact lens

Interventions

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balafilcon A contact lens (PureVision)

Commercially marketed, silicone hydrogel contact lens

Intervention Type DEVICE

etafilcon A contact lens (Acuvue2)

Commercially marketed, hydrogel contact lens

Intervention Type DEVICE

Other Intervention Names

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PureVision Acuvue2

Eligibility Criteria

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Inclusion Criteria

* Age 18 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.

Exclusion Criteria

* Evidence or history of ocular conditions as prescribed in the protocol.
* One functional eye or a monofit lens.
* Any slit-lamp finding score of (1) at the Screening Visit as defined by the protocol.
* Use of concomitant topical ocular prescription or over-the-counter ocular medications.
* History of seasonal allergies with significant ocular side effects.
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-007

Identifier Type: -

Identifier Source: org_study_id