Air Optix Extended Wear Contact Lenses

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 Aqua Sphere, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as extended (overnight) wear.

Detailed Description
-----------------
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. Subjects/charts meeting the eligibility criteria will be enrolled in the study. The data collection period is defined as any approximately 1-year to 3-year timeframe since the respective lens brand was prescribed.

Official Title
-----------------
Air Optix Extended Wear Contact Lenses

Conditions
-----------------
Refractive Errors

Intervention / Treatment
-----------------
* Device: Lotrafilcon B spherical soft contact lenses
* Device: Lotrafilcon B spherical soft contact lenses with comfort additive
* Device: Lotrafilcon B toric soft contact lenses with comfort additive
* Device: Comfilcon A spherical soft contact lenses
* Device: Comfilcon A toric soft contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline (sphere wearers only); Best corrected visual acuity (BCVA) of 20/25 Snellen or better in each eye at baseline; Must have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere or Biofinity Toric for at least 3 years in an extended wear modality, as determined by the Investigator; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any recurrent history or active anterior segment infection, inflammation or abnormality contraindicating regular contact lens wear at baseline; Use of systemic or ocular medications contraindicating regular contact lens wear at baseline and/or during the period of the retrospective chart collection; Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear; Other protocol-defined 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 |
| --- | --- |
| Air Optix Aqua Sphere<br>Lotrafilcon B spherical soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). | Device: Lotrafilcon B spherical soft contact lenses<br>* Commercially available silicone hydrogel contact lenses<br>* Other names: Air Optix® Aqua Sphere;|
| Air Optix plus HydraGlyde Sphere<br>Lotrafilcon B multifocal soft contact lenses with comfort additive worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). | Device: Lotrafilcon B spherical soft contact lenses with comfort additive<br>* Commercially available silicone hydrogel contact lenses<br>* Other names: Air Optix® plus HydraGlyde® Sphere;|
| Air Optix plus HydraGlyde Toric<br>Lotrafilcon B toric soft contact lenses with comfort additive worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). | Device: Lotrafilcon B toric soft contact lenses with comfort additive<br>* Commercially available silicone hydrogel contact lenses<br>* Other names: Air Optix® plus HydraGlyde® Toric;|
| Biofinity Sphere<br>Comfilcon A spherical soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). | Device: Comfilcon A spherical soft contact lenses<br>* Commercially available silicone hydrogel contact lenses<br>* Other names: Biofinity Sphere;|
| Biofinity Toric<br>Comfilcon A toric soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). | Device: Comfilcon A toric soft contact lenses<br>* Commercially available silicone hydrogel contact lenses<br>* Other names: Biofinity Toric;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance visual acuity (VA) with study lenses at Year 1 | The subject's chart will be reviewed for distance visual acuity at Year 1, defined as a visit which occurred 1 year (-2/+4 months) since baseline during which period the subject was wearing either the study or comparator lenses and a contact lens examination was performed. The Baseline visit is defined as the first office visit where an eye care practitioner provided an in-person office biomicroscopy exam to the patient before or during which a contact lens prescription for the study or comparator contact lens (lotrafilcon B or comfilcon A) was released. | Year 1 | 
| Distance visual acuity (VA) with study lenses at Year 3 | The subject's chart will be reviewed for distance visual acuity at Year 3, defined as a visit which occurred 3 years (-2/+8 months) since baseline during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed. | Year 3 | 
| 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 3 | 
| Incidence of microbial keratitis | The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. | Up to Year 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact Lenses