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The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.
Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P1fA, then MyDay Toric | Other | Verofilcon A toric contact lenses worn first, with stenfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality. |
|
| MyDay Toric, then P1fA | Other | Stenfilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verofilcon A toric contact lenses | Device | Soft contact lenses for optical correction of astigmatism, used as indicated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion | Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis. | Day 1, 10 minutes after lens insertion, each product |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigator 6565 | Maitland | Florida | 32751 | United States | ||
| Alcon Investigator 6567 |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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|
| Stenfilcon A toric contact lenses | Device | Soft contact lenses for optical correction of astigmatism, used as indicated |
|
|
| Pittsburg |
| Kansas |
| 66762 |
| United States |
| Alcon Investigator 8097 | Sterling Heights | Michigan | 48312 | United States |
| Alcon Investigator 6313 | Powell | Ohio | 43065 | United States |
| Alcon Investigator 6401 | Warwick | Rhode Island | 02888 | United States |
| Alcon Investigator 6353 | Memphis | Tennessee | 38111 | United States |