A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-04-30

Brief Summary

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The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric 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

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Investigational Toric Lens

Bausch + Lomb investigational toric contact lenses

Group Type EXPERIMENTAL

Investigational Toric Lens

Intervention Type DEVICE

Bausch \& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.

PureVision Toric Lens

Currently marketed Bausch + Lomb PureVision toric contact lenses

Group Type ACTIVE_COMPARATOR

PureVision Toric Lens

Intervention Type DEVICE

Currently marked Bausch \& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.

Interventions

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Investigational Toric Lens

Bausch \& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.

Intervention Type DEVICE

PureVision Toric Lens

Currently marked Bausch \& Lomb PureVision Toric Lens 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 lens wearers, wear a lens in each eye and each lens must be of the same manufacture and brand.
* Subjects must be myopic and require lens correction
* Subjects must be habitual wearers of toric soft contact lenses.

Exclusion Criteria

* Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
* 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 who are using any ocular medication.
* Subjects with any grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects who are allergic to any component in the study care products.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes