Evaluation of the Feasibility 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

2011-02-28

Brief Summary

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The objective of this study is to determine the clinical feasibility and to evaluate the product performance of an investigational contact lens.

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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 lens

Bausch \& Lomb investigational silicone hydrogel lens

Group Type EXPERIMENTAL

Investigational lens

Intervention Type DEVICE

Bausch \& Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week.

Air Optix Aqua lens

Ciba Vision Air Optix Aqua contact lens

Group Type ACTIVE_COMPARATOR

Air Optix Aqua lens

Intervention Type DEVICE

Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week.

Interventions

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Investigational lens

Bausch \& Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week.

Intervention Type DEVICE

Air Optix Aqua lens

Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Be myopic and require lens correction in each eye.
* 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

* 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