Air Optix® Night and Day® Aqua Continuous Wear

Study Overview
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Brief Summary
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The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.

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. Subjects/charts meeting the eligibility criteria will be enrolled in the study. The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows: The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a contact lens prescription for AONDA or PureVision 2 (PV2) was released. The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed. The data collection period is defined as any approximately 3-year timeframe since and including 2009.

Official Title
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Air Optix® Night and Day® Aqua Continuous Wear

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: Lotrafilcon A contact lenses
* Device: Balafilcon A 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 in each eye at baseline Best corrected visual acuity of 20/25 or better in each eye at baseline At the time of Year 3 Visit, subject was prescribed and wearing AONDA or PV2 contact lenses in both eyes in a 30-day continuous wear modality for at least approximately 3 years Baseline Visit and Year 3 Visit charts available Key Exclusion Criteria: Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at baseline The use of systemic or ocular medications contraindicating regular contact lens wear at baseline History of refractive surgery or irregular cornea Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear at baseline

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| AONDA contact lenses<br>Lotrafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years | Device: Lotrafilcon A contact lenses<br>* CE-marked silicone hydrogel contact lenses<br>* Other names: AONDA;|
| PV2 contact lenses<br>Balafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years | Device: Balafilcon A contact lenses<br>* CE-marked silicone hydrogel contact lenses<br>* Other names: PV2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance visual acuity | The subject's chart will be reviewed for distance visual acuity. | Year 3 | 
| Incidence of corneal infiltrative events | The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the Baseline Visit 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 Visit exam. | Up to Year 3 | 

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