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Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS)

NCT ID: NCT00733291

Last Updated: 2011-12-28

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-02-29

Brief Summary

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The purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027.

Detailed Description

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Corneal staining and subjective responses for ocular redness and comfort will be compared.

Conditions

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Myopia

Keywords

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Daily disposable contact lenses Multi-purpose disinfecting solutions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nelfilcon A soak / Nelfilcon A no-soak

Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.

Group Type ACTIVE_COMPARATOR

Nelfilcon A contact lens

Intervention Type DEVICE

Commercially marketed, single vision, soft contact lens for daily disposable wear

FID 107027 solution

Intervention Type DEVICE

Commercially marketed solution for contact lens disinfection

Nelfilcon A no soak / nelfilcon A soak

Nelfilcon A contact lenses inserted directly from the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.

Group Type ACTIVE_COMPARATOR

Nelfilcon A contact lens

Intervention Type DEVICE

Commercially marketed, single vision, soft contact lens for daily disposable wear

FID 107027 solution

Intervention Type DEVICE

Commercially marketed solution for contact lens disinfection

Etafilcon A soak / etafilcon A no soak

Etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by etafilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.

Group Type ACTIVE_COMPARATOR

Etafilcon A contact lens

Intervention Type DEVICE

Commercially marketed, single vision, soft contact lens for daily disposable wear

FID 107027 solution

Intervention Type DEVICE

Commercially marketed solution for contact lens disinfection

Etafilcon A no soak / etafilcon A soak

Etafilcon A contact lenses inserted directly from the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.

Group Type ACTIVE_COMPARATOR

Etafilcon A contact lens

Intervention Type DEVICE

Commercially marketed, single vision, soft contact lens for daily disposable wear

FID 107027 solution

Intervention Type DEVICE

Commercially marketed solution for contact lens disinfection

Interventions

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Nelfilcon A contact lens

Commercially marketed, single vision, soft contact lens for daily disposable wear

Intervention Type DEVICE

Etafilcon A contact lens

Commercially marketed, single vision, soft contact lens for daily disposable wear

Intervention Type DEVICE

FID 107027 solution

Commercially marketed solution for contact lens disinfection

Intervention Type DEVICE

Other Intervention Names

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Focus Dailies with AquaRelease 1-Day ACUVUE Moist Opti-Free RepleniSH Multi-Purpose Disinfecting Solution

Eligibility Criteria

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Inclusion Criteria

* 18 years of age 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 on a daily wear basis for at least two weeks prior to study.

Exclusion Criteria

* History of hypersensitivity to any components of the multi-purpose solution.
* Evidence or history of ocular conditions as prescribed in protocol.
* One functional eye or a monofit lens
* Any slit-lamp finding score equal to 1 at Visit 1 of each study period.
* Significant corneal staining at visit 1 of each study period as prescribed in protocol.
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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Contact 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-008

Identifier Type: -

Identifier Source: org_study_id