Four Week Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

Study Overview
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Brief Summary
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The purpose of this study is to compare the performance of two commercially marketed contact lenses when worn for up to 4 weeks in a daily wear modality.

Official Title
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4 Week Performance Comparison Between 2 Commercially Available Silicone Hydrogel Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Lotrafilcon B contact lens (AIR OPTIX® AQUA)
* Device: Balafilcon A contact lens (PureVision® 2)
* Device: Contact lens solution (Clear Care®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Habitual spherical soft contact lens wearer who wears a contact lens brand with a recommended replacement schedule of 2 weeks or greater. Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses. Willing and able to wear spherical contact lenses within the available range of powers. Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks prior to enrollment. Currently enrolled in any clinical trial. Any use of medications for which contact lens wear could be contraindicated as determined by the investigator. Astigmatism of 1.00D or more. Currently wearing contact lenses in a daily disposable modality. Currently wearing AIR OPTIX AQUA or PureVision 2 contact lenses Currently sleeping overnight in contact lenses on an occasional or extended wear basis. Other protocol-defined exclusion criteria may apply.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lotrafilcon B<br>Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality. | Device: Lotrafilcon B contact lens (AIR OPTIX® AQUA)<br>* Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.<br>* Other names: AIR OPTIX® AQUA;Device: Contact lens solution (Clear Care®)<br>* Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.<br>* Other names: Clear Care®;|
| Active Comparator: Balafilcon A<br>Balafilcon A commercially marketed contact lens randomly assigned to one eye, with lotrafilcon B commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality. | Device: Balafilcon A contact lens (PureVision® 2)<br>* Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.<br>* Other names: PureVision® 2;Device: Contact lens solution (Clear Care®)<br>* Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.<br>* Other names: Clear Care®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort on Insertion | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks | 
| Comfort During the Day | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks | 
| Comfort at End of Day | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks | 
| Overall Comfort | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks | 
| Daytime Vision | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks | 
| Low Light Vision | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks | 
| Handling on Insertion | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy. | 4 weeks | 
| Handling at Removal | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy. | 4 weeks | 
| Delivers a Healthy, Natural Feeling | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks | 
| Lens Awareness | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware. | 4 weeks | 
| Overall Satisfaction | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks | 
| Purchase Intent | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, How likely would you be to purchase these lenses? Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses. | 4 weeks |