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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air Optix Aqua Sphere | 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). |
| |
| Air Optix plus HydraGlyde Sphere | 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). |
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| Air Optix plus HydraGlyde Toric | 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). |
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| Biofinity Sphere | 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). |
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| Biofinity Toric | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B spherical soft contact lenses | Device | Commercially available silicone hydrogel contact lenses |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Investigators will enroll charts following a pre-identified process.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision Health Institute | Orlando | Florida | 32803 | United States | ||
| Complete Eye Care of Medina |
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| Lotrafilcon B spherical soft contact lenses with comfort additive | Device | Commercially available silicone hydrogel contact lenses |
|
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| Lotrafilcon B toric soft contact lenses with comfort additive | Device | Commercially available silicone hydrogel contact lenses |
|
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| Comfilcon A spherical soft contact lenses | Device | Commercially available silicone hydrogel contact lenses |
|
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| Comfilcon A toric soft contact lenses | Device | Commercially available silicone hydrogel contact lenses |
|
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| Medina |
| Minnesota |
| 55340 |
| United States |
| Koetting Associates | St Louis | Missouri | 63144 | United States |
| Smith Bowman Ophthalmology | Salt Lake City | Utah | 84117 | United States |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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