Comparison of Two Marketed Silicone Hydrogel Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.

Official Title
-----------------
One Month Clinical Comparison of Lotrafilcon B and Samfilcon A

Conditions
-----------------
Refractive Error

Intervention / Treatment
-----------------
* Device: Lotrafilcon B contact lenses
* Device: Samfilcon A contact lenses
* Device: Hydrogen peroxide solution
* Device: Saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign informed consent document; Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses; Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits; Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included); Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current); History of herpetic keratitis, corneal surgery or irregular cornea; Any use of systemic or ocular medications within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator; Monocular (only 1 eye with functional vision) or fit with only one lens; Current or past AIR OPTIX® AQUA or ULTRA lens wearers; Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AOA then ULTRA<br>Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality. | Device: Lotrafilcon B contact lenses<br> <br> * Other names: AIR OPTIX® AQUA;Device: Samfilcon A contact lenses<br> <br> * Other names: Bausch + Lomb ULTRA;Device: Hydrogen peroxide solution<br>* Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses<br>* Other names: CLEAR CARE®;Device: Saline solution<br>* Used for rinsing contact lenses, as needed<br>* Other names: SENSITIVE EYES® PLUS;|
| Other: ULTRA then AOA<br>Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality. | Device: Lotrafilcon B contact lenses<br> <br> * Other names: AIR OPTIX® AQUA;Device: Samfilcon A contact lenses<br> <br> * Other names: Bausch + Lomb ULTRA;Device: Hydrogen peroxide solution<br>* Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses<br>* Other names: CLEAR CARE®;Device: Saline solution<br>* Used for rinsing contact lenses, as needed<br>* Other names: SENSITIVE EYES® PLUS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear | The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error. | Day 30, each product |