Evaluation of a New Silicone Hydrogel Contact Lens

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-01-31

Brief Summary

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The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.

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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

Blinding Strategy

SINGLE

Participants

Study Groups

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Air Optix Aqua

Ciba Vision daily wear contact lens

Group Type ACTIVE_COMPARATOR

Air Optix Aqua

Intervention Type DEVICE

Air Optix Aqua contact lens worn on a daily wear basis

Test Lens

Investigational silicone hydrogel contact lens

Group Type EXPERIMENTAL

Test lens

Intervention Type DEVICE

Investigational silicone hydrogel contact lens worn on a daily wear basis

Interventions

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Test lens

Investigational silicone hydrogel contact lens worn on a daily wear basis

Intervention Type DEVICE

Air Optix Aqua

Air Optix Aqua contact lens worn on a daily wear basis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

Exclusion Criteria

* Have worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* An active ocular disease, any corneal infiltrative response or are using any ocular medications.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Allergic to any component in the study care products.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes