Clinical Comparison of Toric Contact Lenses Fit Characteristics
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the fit characteristics between four Alcon commercially available toric contact lenses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: DT1fA/T30fA/AOHGfA/P1fA 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. |
Device: Delefilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
Device: Lehfilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
Device: Lotrafilcon B toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
Device: Verofilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
|
| Other: T30fA/AOHGfA/P1fA/DT1fA 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. |
Device: Delefilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
Device: Lehfilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
Device: Lotrafilcon B toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
Device: Verofilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
|
| Other: AOHGfA/P1fA/DT1fA/T30fA 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. |
Device: Delefilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
Device: Lehfilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
Device: Lotrafilcon B toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
Device: Verofilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
|
| Other: P1fA/DT1fA/T30fA/AOHGfA 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. |
Device: Delefilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
Device: Lehfilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
Device: Lotrafilcon B toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
Device: Verofilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Distance VA with study lenses [30 mins (± 15 mins), each product]
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.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
-
Able to be fit with contact lenses within the available range of sphere, cylinder power, and axes (based on lens availability).
-
Best Corrected Visual Acuity (BCVA) better than or equal to 0.10 (logMAR) in each eye.
-
Willing to stop wearing habitual contact lenses during in-office visits.
-
Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
-
Current spherical, monovision or multifocal lens wearer.
-
Protocol-specified biomicroscopy findings at screening.
-
Current or history of herpetic keratitis in either eye.
-
Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
-
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kurata Eyecare Center | Los Angeles | California | United States | 90013 |
| 2 | Omega Vision Center P.A. | Longwood | Florida | United States | 32779 |
| 3 | Kindred Optics at Maitland Vision | Maitland | Florida | United States | 32751 |
| 4 | Kannarr Eye Care LLC | Pittsburg | Kansas | United States | 66762 |
| 5 | ProCare Vision Centers, Inc. | Granville | Ohio | United States | 43023 |
| 6 | Optometry Group, PLLC | Memphis | Tennessee | United States | 38111 |
| 7 | Clarke EyeCare Center | Wichita Falls | Texas | United States | 76308 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Chair: Clinical Trial Lead, Vision Care, Alcon Research, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLF993-P001