Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to compare an experimental contact lens with a currently marketed 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

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental Lotrafilcon A Contact Lens

Lotrafilcon A experimental contact lens randomly assigned to one eye

Group Type EXPERIMENTAL

Lotrafilcon A Experimental Contact Lens

Intervention Type DEVICE

Experimental spherical, silicone hydrogel soft contact lens

Commercial Lotrafilcon A Contact Lens

Lotrafilcon A commercial contact lens randomly assigned to one eye

Group Type ACTIVE_COMPARATOR

Lotrafilcon A Commercial Contact Lens

Intervention Type DEVICE

Commercially marketed spherical, silicone hydrogel soft contact lens

Interventions

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Lotrafilcon A Experimental Contact Lens

Experimental spherical, silicone hydrogel soft contact lens

Intervention Type DEVICE

Lotrafilcon A Commercial Contact Lens

Commercially marketed spherical, silicone hydrogel soft contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day
* On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses

Exclusion Criteria

* Requires concurrent ocular medication
* Eye injury or surgery within twelve weeks immediately prior to enrollment
* Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
* Any active corneal infection
* Any use of medications for which contact lens wear would be contraindicated
* History of corneal refractive surgery
* Wears toric contact lenses

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No