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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air Optix Aqua Sphere | Lotrafilcon B spherical soft contact lenses worn in both eyes and removed daily for cleaning and disinfection |
| |
| Air Optix plus HydraGlyde Sphere | Lotrafilcon B spherical soft contact lenses with comfort additive worn in both eyes and removed daily for cleaning and disinfection |
| |
| Air Optix plus HydraGlyde Toric | Lotrafilcon B toric soft contact lenses with comfort additive worn in both eyes and removed daily for cleaning and disinfection |
| |
| Biofinity Sphere | Comfilcon A spherical soft contact lenses worn in both eyes and removed daily for cleaning and disinfection |
| |
| Biofinity Toric | Comfilcon A toric soft contact lenses worn in both eyes and removed daily for cleaning and disinfection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B spherical soft contact lenses | Device | Commercially available silicone hydrogel contact lenses |
|
| 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 |
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Key Inclusion Criteria:
Key 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 |
|
|
| Lotrafilcon B toric soft contact lenses with comfort additive | Device | Commercially available silicone hydrogel contact lenses |
|
|
| Comfilcon A spherical soft contact lenses | Device | Commercially available silicone hydrogel contact lenses |
|
|
| Comfilcon A toric soft contact lenses | Device | Commercially available silicone hydrogel contact lenses |
|
|
| Medina |
| Minnesota |
| 55340 |
| United States |
| Koetting Associates | St Louis | Missouri | 63144 | United States |
| Toyos Clinic | Nashville | Tennessee | 37215 | 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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