Air Optix® Night and Day® Aqua Daily Wear

Study Overview
=================
Brief Summary
-----------------
The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as daily wear for vision correction.

Detailed Description
-----------------
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will review charts within their existing database to identify subjects who wore AONDA contact lenses or PureVision® 2 (PV2) contact lenses in both eyes for approximately 1 year following their contact lens examination. The data collection period consists of any approximately 1-year timeframe since and including 2009. The anticipated duration of the study is approximately 6 months.

Official Title
-----------------
Air Optix® Night and Day® Aqua Daily Wear

Conditions
-----------------
Refractive Errors, Myopia, Hyperopia

Intervention / Treatment
-----------------
* Device: Lotrafilcon A contact lenses
* Device: Balafilcon A contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal eyes, as determined by the Investigator At the time of the 1-year visit, subject was prescribed and wearing AONDA contact lenses or PV2 contact lenses in both eyes in a daily wear modality for at least approximately 1 year without changing wear modality Baseline and 1-year visit charts available Other protocol-specified inclusion criteria may apply Exclusion Criteria Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at Baseline Use of systemic or ocular medications contraindicating regular contact lens wear at Baseline History of refractive surgery or irregular cornea 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AONDA contact lenses<br>Lotrafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional | Device: Lotrafilcon A contact lenses<br>* CE-marked silicone hydrogel contact lenses for daily wear use<br>* Other names: Air Optix® Night and Day® Aqua;|
| PV2 contact lenses<br>Balafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional | Device: Balafilcon A contact lenses<br>* CE-marked silicone hydrogel contact lenses for daily wear use<br>* Other names: PureVision® 2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance visual acuity by eye | The subject's chart will be reviewed for distance visual acuity. | Year 1 | 
| Incidence of corneal infiltrative events | The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam. | Up to Year 1 | 
| Incidence of microbial keratitis | The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. | Up to Year 1 |