AIR OPTIX® COLORS Registration Trial

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this study was to evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs.

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Detailed Description

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This study consisted of 7 scheduled visits conducted over a 3-month period. Enrolled participants were randomized (2:1) to receive either AIR OPTIX® COLORS lenses in both eyes or AIR OPTIX® AQUA lenses in both eyes.

Conditions

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Refractive Error

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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AIR OPTIX® COLORS

Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months

Group Type EXPERIMENTAL

Lotrafilcon B contact lens with color

Intervention Type DEVICE

Silicone hydrogel contact lens with color

AIR OPTIX® AQUA

Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months

Group Type ACTIVE_COMPARATOR

Lotrafilcon B contact lens

Intervention Type DEVICE

Silicone hydrogel contact lens

Interventions

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Lotrafilcon B contact lens with color

Silicone hydrogel contact lens with color

Intervention Type DEVICE

Lotrafilcon B contact lens

Silicone hydrogel contact lens

Intervention Type DEVICE

Other Intervention Names

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AIR OPTIX® COLORS AIR OPTIX® AQUA

Eligibility Criteria

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Inclusion Criteria

* Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
* Normal eyes and not using any ocular medications.
* Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges.
* Manifest cylinder less than or equal to 0.75 diopter.
* Best spectacle corrected visual acuity greater than or equal to 20/25.
* Have current prescription glasses.

Exclusion Criteria

* Anterior segment infection, inflammation, or abnormality.
* Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear.
* Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
* History of refractive surgery or irregular cornea.
* History of pathologically dry eye.
* Corneal vascularization greater than 1 millimeter of penetration.
* History of herpetic keratitis.
* Eye injury within 12 weeks immediately prior to enrollment in this trial.
* Currently enrolled in any clinical trial or participation in any clinical trial within the previous 30 days.

Eligible Sex

ALL

Accepts Healthy Volunteers

No