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Management decision
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The purpose of this study is to assess long term performance and safety of verofilcon A soft contact lenses in a real-world setting in a population of 7 years or older having at least 1 year of verofilcon A (sphere or toric) contact lens wear in a daily wear and daily disposable modality.
This study consists of a Baseline Visit and a Year 1 Visit.
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 PRECISION1™ sphere or toric contact lens prescription was released. The Baseline Visit will be retrospective, with all assessments obtained from chart review.
The Year 1 Visit is defined as the visit that occurs 1 year (-2/+4 months) since Baseline during which period the subject is wearing test lenses of the same design in both eyes and a contact lens examination is performed during the visit. The Year 1 Visit may be prospective or retrospective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRECISION1 Sphere | Verofilcon A spherical soft contact lenses worn in both eyes in a real-world setting |
| |
| PRECISION1 Toric | Verofilcon A toric soft contact lenses worn in both eyes in a real-world setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verofilcon A spherical soft contact lenses | Device | Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) |
| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity with Study Lenses at Baseline | Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place. | Baseline |
| Distance Visual Acuity with Study Lenses at Year 1 Follow-Up | Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place. | Year 1 |
| Incidence of Corneal Infiltrative Events | A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea. | Up to Year 1 |
| Incidence of Microbial Keratitis | Microbial keratitis is a sight-threatening infection of the cornea. | Up to Year 1 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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Subjects will be recruited from clinical sites located in the United States.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, VC | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Optometric Group | San Diego | California | 92131 | United States | ||
| Pearle Vision |
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| Verofilcon A toric soft contact lenses | Device | Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) with astigmatism |
|
|
| Jacksonville |
| Florida |
| 32246 |
| United States |
| Vision Health Institute | Orlando | Florida | 32803 | United States |
| Vision Salon Eye Care Associates | Blue Island | Illinois | 60406 | United States |
| Illinois College of Optometry | Chicago | Illinois | 60616 | United States |
| CORL, Indiana University | Bloomington | Indiana | 47405 | United States |
| The Eye Doctors Inc | Eden Prairie | Minnesota | 55344 | United States |
| Cornea and Contact Lens Institute of Minnesota | Edina | Minnesota | 55436 | United States |
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States |
| Spectrum Eyecare | Jamestown | New York | 14701 | United States |
| Eyecare Professionals, Inc | Powell | Ohio | 43065 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D006956 | Hyperopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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