Air Optix Plus HydraGlyde Multifocal Daily/Extended 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 plus HydraGlyde Multifocal soft contact lenses in a real-world setting when worn as daily wear or extended (overnight) 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/charts meeting the eligibility criteria will be enrolled in the study.

Official Title
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Air Optix Plus HydraGlyde Multifocal Daily/Extended Wear Contact Lenses

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: Lotrafilcon B multifocal soft contact lenses
* Device: Comfilcon A multifocal soft contact lenses


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Best Corrected Visual Acuity (BCVA) of 20/25 Snellen or better in each eye at baseline; Must have worn or be wearing Air Optix plus Hydraglyde Multifocal or Biofinity Multifocal for at least 1 year in a daily wear modality, or 3 years in an extended wear modality; 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; Participation of the patient in a contact lens or contact lens care product trial during the period of the retrospective chart collection; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 40 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Air Optix plus HydraGlyde Multifocal Daily Wear<br>Lotrafilcon B multifocal soft contact lenses with comfort additive worn in both eyes and removed daily for cleaning and disinfection | Device: Lotrafilcon B multifocal soft contact lenses<br>* Commercially available soft (hydrophilic) contact lenses indicated for the correction of presbyopia, with or without myopia or hyperopia<br>* Other names: Air Optix plus HydraGlyde Multifocal Extended Wear;|
| Air Optix plus HydraGlyde Multifocal Extended Wear<br>Lotrafilcon B multifocal soft contact lenses with comfort additive worn in both eyes worn on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). | Device: Lotrafilcon B multifocal soft contact lenses<br>* Commercially available soft (hydrophilic) contact lenses indicated for the correction of presbyopia, with or without myopia or hyperopia<br>* Other names: Air Optix plus HydraGlyde Multifocal Extended Wear;|
| Biofinity Multifocal Daily Wear<br>Comfilcon A multifocal soft contact lenses worn in both eyes and removed daily for cleaning and disinfection | Device: Comfilcon A multifocal soft contact lenses<br>* Commercially available soft (hydrophilic) contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia<br>* Other names: Biofinity Multifocal Extended Wear;|
| Biofinity Multifocal Extended Wear<br>Comfilcon A multifocal soft contact lenses worn in both eyes worn on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight). | Device: Comfilcon A multifocal soft contact lenses<br>* Commercially available soft (hydrophilic) contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia<br>* Other names: Biofinity Multifocal Extended Wear;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance visual acuity at 1 year - Daily Wear | The subject's chart will be reviewed for distance visual acuity at Year 1, defined as the visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear). | Year 1 | 
| Near visual acuity at 1 year - Daily Wear | The subject's chart will be reviewed for near visual acuity at Year 1, defined as the visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear). | Year 1 | 
| Distance visual acuity at 3 years - Extended Wear | The subject's chart will be reviewed for distance visual acuity at Year 3, defined as the 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. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear). | Year 3 | 
| Near visual acuity at 3 years - Extended Wear | The subject's chart will be reviewed for near visual acuity at Year 3, defined as the 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. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear). | Year 3 | 
| Incidence of corneal infiltrative events - Daily Wear | The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear). | Up to Year 1 | 
| Incidence of corneal infiltrative events - Extended Wear | The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear). | Up to Year 3 | 
| Incidence of microbial keratitis - Daily Wear | The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear). | Up to Year 1 | 
| Incidence of microbial keratitis - Extended Wear | The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear). | Up to Year 3 |