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Management Decision
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The purpose of this study is to compare the fit characteristics between four Alcon commercially available toric contact lenses.
Subjects will be expected to attend 3 visits including the screening visit. The total duration of a subject's participation in the study will be approximately 19 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DT1fA/T30fA/AOHGfA/P1fA | Other | DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. |
|
| T30fA/AOHGfA/P1fA/DT1fA | Other | T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. |
|
| AOHGfA/P1fA/DT1fA/T30fA | Other | AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. |
|
| P1fA/DT1fA/T30fA/AOHGfA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A toric soft contact lens | Device | Commercially available silicone hydrogel contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance VA with study lenses | Visual Acuity (VA) will be assessed using letter charts with study lenses in place and reported in logarithm minimum angle of resolution (logMAR). A logMAR value of 0.0 equates to 20/20 Snellen, which is considered normal distance eyesight. Eyes will be assessed individually. | 30 mins (± 15 mins), 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurata Eyecare Center | Los Angeles | California | 90013 | United States | ||
| Omega Vision Center P.A. |
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P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. |
|
|
| Lehfilcon A toric soft contact lens | Device | Commercially available silicone hydrogel contact lens |
|
|
| Lotrafilcon B toric soft contact lens | Device | Commercially available silicone hydrogel contact lens |
|
|
| Verofilcon A toric soft contact lens | Device | Commercially available silicone hydrogel contact lens |
|
|
| Longwood |
| Florida |
| 32779 |
| United States |
| Kindred Optics at Maitland Vision | Maitland | Florida | 32751 | United States |
| Kannarr Eye Care LLC | Pittsburg | Kansas | 66762 | United States |
| ProCare Vision Centers, Inc. | Granville | Ohio | 43023 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| Clarke EyeCare Center | Wichita Falls | Texas | 76308 | United States |
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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