Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers

NCT ID: NCT00985231

Last Updated: 2015-03-24

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

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

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This study is being conducted to evaluate Bausch \& Lomb PureVision Multi-Focal contact lenses compared to the Bausch \& Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.

Detailed Description

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Conditions

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Vision Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PureVision Multi-Focal contact lenses

Group Type EXPERIMENTAL

PureVision Multi-Focal contact lenses

Intervention Type DEVICE

Contact lenses to be worn on a daily wear basis for 2 weeks.

SofLens59 contact lens

Group Type ACTIVE_COMPARATOR

SofLens59 contact lens

Intervention Type DEVICE

Contact lenses to be worn on a daily wear basis for 2 weeks.

Interventions

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PureVision Multi-Focal contact lenses

Contact lenses to be worn on a daily wear basis for 2 weeks.

Intervention Type DEVICE

SofLens59 contact lens

Contact lenses to be worn on a daily wear basis for 2 weeks.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
* Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.

Exclusion Criteria

* Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
* Subjects with any systemic disease affecting ocular health
* Subjects with an active ocular disease or using any ocular medication.
* Subjects who have had any corneal surgery (eg, refractive surgery).
Minimum Eligible Age

30 Years

Maximum Eligible Age

40 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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Beverly J Barna

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Bausch & Lomb

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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630

Identifier Type: -

Identifier Source: org_study_id

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