Comparative Performance of PureVision Lens Designs

NCT ID: NCT00661687

Last Updated: 2011-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-06-30

Brief Summary

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The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous 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

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Purevision Contact Lens #1

PureVision Soft Contact Lens Design (currently marketed)

Group Type ACTIVE_COMPARATOR

Currently Marketed PureVision Contact Lens.

Intervention Type DEVICE

Contact lens for continuous wear

PureVision Contact Lens #2

Redesign of the currently marketed PureVision soft contact lens.

Group Type EXPERIMENTAL

Alternate Design of the PureVision Contact Lens.

Intervention Type DEVICE

Contact lens for continuous wear

Interventions

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Currently Marketed PureVision Contact Lens.

Contact lens for continuous wear

Intervention Type DEVICE

Alternate Design of the PureVision Contact Lens.

Contact lens for continuous 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

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

Benny Chian, MCOptom

Role: PRINCIPAL_INVESTIGATOR

Laser Focus Sdn Bhd, Vision Correction Centre

Harvey Siy Uy, MD

Role: PRINCIPAL_INVESTIGATOR

Asian Eye Institute

Locations

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Laser Focus Sdn Bhd, Vision Correction Centre

Johor Bahru, Johor Bahru, Malaysia

Site Status

Asian Eye Institute

Makati City, , Philippines

Site Status

Countries

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Malaysia Philippines

Other Identifiers

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544

Identifier Type: -

Identifier Source: org_study_id