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Management decision
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The purpose of this study is to continuously assess the visual performance and safety of DAILIES TOTAL1 soft contact lenses in a real world setting and broader patient base through routine clinical practices. This activity will be used to continuously support delefilcon A (sphere, toric, and multifocal) soft contact lens regulatory requirements and standards.
This study includes 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 DAILIES TOTAL1 sphere, toric, or multifocal soft contact lens prescription was released. The Baseline visit will be retrospective. All assessments at baseline will be obtained from chart reviews.
The Year 1 visit is defined as the visit that occurs 1 year (-2/+4 months) since the Baseline visit during which period the subject is wearing prescribed lenses and a contact lens examination is performed. The Year 1 visit can be either retrospective or prospective in subjects 7 to less than 18 years of age. For subjects 18 years of age and older, the Year 1 visit will be retrospective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAILIES TOTAL1 Sphere | Delefilcon A spherical soft contact lenses worn in both eyes in a real-world setting |
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| DAILIES TOTAL1 Toric | Delefilcon A toric soft contact lenses worn in both eyes in a real-world setting |
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| DAILIES TOTAL1 Multifocal | Delefilcon A multifocal soft contact lenses worn in both eyes in a real-world setting |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon 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 (VA) with study lenses at Baseline - Sphere and Toric | Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses. | Baseline |
| Distance visual acuity with study lenses at Year 1 Follow-up - Sphere and Toric | Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses. | Year 1 Follow-Up |
| Distance visual acuity with study lenses at Baseline - Multifocal | Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses. | Baseline |
| Distance visual acuity with study lenses at Year 1 Follow-Up - Multifocal | Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses. | Year 1 Follow-Up |
| Near visual acuity with study lenses at Baseline - Multifocal | Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses. | Baseline |
| Near visual acuity with study lenses at Year 1 Follow-Up - Multifocal |
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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, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westview Optometry | San Diego | California | 92129 | United States | ||
| Scripps Optometric Group |
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| Delefilcon 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 |
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| Delefilcon A multifocal 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 presbyopia |
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Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses. |
| Year 1 Follow-Up |
| 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 |
| San Diego |
| California |
| 92131 |
| United States |
| Dr. Walker and Associates | Ponte Vedra Beach | Florida | 32082 | United States |
| Advanced Eyecare Specialists | West Palm Beach | Florida | 33405 | 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 |
| Koetting Associates | St Louis | Missouri | 63144 | United States |
| Center for Ophthalmic and Vision Research | New York | New York | 10022 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| Southern Utah Medical Research | St. George | Utah | 84790 | United States |
| Spokane Eye Clinic | Spokane | Washington | 99204 | United States |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| D011305 | Presbyopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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