Air Optix Daily Wear Contact Lenses

Study Overview
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Brief Summary
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The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix Aqua, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as daily wear.

Detailed Description
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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. The baseline visit will be 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 lenses was released. Subjects meeting the eligibility criteria will be enrolled in the study.

Official Title
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Air Optix Daily Wear Contact Lenses

Conditions
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Refractive Errors

Intervention / Treatment
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* 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
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Eligibility Criteria
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Key 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 1 year in a daily wear modality, as determined by the Investigator; Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere, or Biofinity Toric contact lenses in an extended wear modality; 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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Air Optix Aqua Sphere<br>Lotrafilcon B spherical soft contact lenses worn in both eyes and removed daily for cleaning and disinfection | 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 spherical soft contact lenses with comfort additive worn in both eyes and removed daily for cleaning and disinfection | 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 and removed daily for cleaning and disinfection | 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 and removed daily for cleaning and disinfection | 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 and removed daily for cleaning and disinfection | Device: Comfilcon A toric soft contact lenses<br>* Commercially available silicone hydrogel contact lenses<br>* Other names: Biofinity Toric;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance visual acuity (VA) with study lenses | The subject's chart will be reviewed for distance visual acuity at baseline and at 1 year following the baseline exam. | Up to 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 | 

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