Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-07-31

Brief Summary

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The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.

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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

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Redesigned Purevision Contact Lens

Redesigned Bausch \& Lomb PureVision contact lens

Group Type EXPERIMENTAL

Redesigned Purevision Contact Lens

Intervention Type DEVICE

Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.

PureVision Contact Lens

Bausch \& Lomb PureVision contact lens

Group Type ACTIVE_COMPARATOR

PureVision Contact Lens

Intervention Type DEVICE

Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.

Interventions

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Redesigned Purevision Contact Lens

Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.

Intervention Type DEVICE

PureVision Contact Lens

Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.

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 wearers of one of the listed contact lenses
* Subjects must be myopic
* Subjects must use a lens care system on a regular basis.

Exclusion Criteria

* Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months.
* Subjects with any systemic disease affecting ocular health.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or are using any ocular medication.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects who have had any corneal surgery (eg, refractive surgery).
* Subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No