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Comparative Performance of PureVision, Acuvue Oasys and O2Optix

NCT ID: NCT00640341

Last Updated: 2011-12-12

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

PHASE4

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-04-30

Brief Summary

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The objective of this study is to evaluate the performance of the PureVision Contact Lens compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear basis.

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

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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PureVision

PureVision Contact Lens

Group Type EXPERIMENTAL

PureVision Contact Lens

Intervention Type DEVICE

contact lens for daily wear

Acuvue Oasys

Acuvue Oasys Contact Lens

Group Type ACTIVE_COMPARATOR

Acuvue Oasys Contact Lens

Intervention Type DEVICE

contact lens for daily wear

O2Optix

O2Optix Contact Lens

Group Type ACTIVE_COMPARATOR

O2Optix Contact lens

Intervention Type DEVICE

contact lens for daily wear

Interventions

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PureVision Contact Lens

contact lens for daily wear

Intervention Type DEVICE

Acuvue Oasys Contact Lens

contact lens for daily wear

Intervention Type DEVICE

O2Optix Contact lens

contact lens for daily wear

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is myopic
* VA correctable to 0.3 LogMAR or better (driving vision)
* Clear central cornea
* Subject uses a lens care system on a regular basis

Exclusion Criteria

* Systemic disease affecting ocular health
* Using systemic or topical medications
* Wear monovision, multifocal or toric contact lenses
* Any grade 2 or greater slit lamp findings
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerard Cairns, MCOptom, PhD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Bruce Anderson, OD

Role: PRINCIPAL_INVESTIGATOR

Anderson & Associates

Locations

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Anderson & Associates

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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552

Identifier Type: -

Identifier Source: org_study_id