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The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.
This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test, then Control | Other | DT1 Toric contact lenses worn first, followed by AO1DfA contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour. |
|
| Control, then Test | Other | AO1DfA contact lenses worn first, followed by DT1 Toric contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DT1 Toric contact lenses | Device | Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion | A slit lamp will be used to observe axis orientation. | Day 1, 10 minutes after lens insertion, each product |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
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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 Investigative Site CT-11 | Maitland | Florida | 32751 | United States | ||
| Alcon Investigative Site CT-27 |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| AO1DfA contact lenses | Device | Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia) |
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| Eden Prairie |
| Minnesota |
| 55344 |
| United States |