Clinical Comparison of Toric Contact Lenses Fit Characteristics

Study Overview
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Brief Summary
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The purpose of this study is to compare the fit characteristics between four Alcon commercially available toric contact lenses.

Detailed Description
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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.

Official Title
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Clinical Comparison of Toric Contact Lenses Fit Characteristics

Conditions
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Astigmatism, Refractive Errors

Intervention / Treatment
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* Device: Delefilcon A toric soft contact lens
* Device: Lehfilcon A toric soft contact lens
* Device: Lotrafilcon B toric soft contact lens
* Device: Verofilcon A toric soft contact lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DT1fA/T30fA/AOHGfA/P1fA<br>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<br>* Commercially available silicone hydrogel contact lens<br>* Other names: DAILIES TOTAL1® for Astigmatism;Device: Lehfilcon A toric soft contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: TOTAL30™ for Astigmatism;Device: Lotrafilcon B toric soft contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: AIR OPTIX® plus HydraGlyde® for Astigmatism;Device: Verofilcon A toric soft contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: PRECISION1® for Astigmatism;|
| Other: T30fA/AOHGfA/P1fA/DT1fA<br>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<br>* Commercially available silicone hydrogel contact lens<br>* Other names: DAILIES TOTAL1® for Astigmatism;Device: Lehfilcon A toric soft contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: TOTAL30™ for Astigmatism;Device: Lotrafilcon B toric soft contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: AIR OPTIX® plus HydraGlyde® for Astigmatism;Device: Verofilcon A toric soft contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: PRECISION1® for Astigmatism;|
| Other: AOHGfA/P1fA/DT1fA/T30fA<br>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<br>* Commercially available silicone hydrogel contact lens<br>* Other names: DAILIES TOTAL1® for Astigmatism;Device: Lehfilcon A toric soft contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: TOTAL30™ for Astigmatism;Device: Lotrafilcon B toric soft contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: AIR OPTIX® plus HydraGlyde® for Astigmatism;Device: Verofilcon A toric soft contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: PRECISION1® for Astigmatism;|
| Other: P1fA/DT1fA/T30fA/AOHGfA<br>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<br>* Commercially available silicone hydrogel contact lens<br>* Other names: DAILIES TOTAL1® for Astigmatism;Device: Lehfilcon A toric soft contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: TOTAL30™ for Astigmatism;Device: Lotrafilcon B toric soft contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: AIR OPTIX® plus HydraGlyde® for Astigmatism;Device: Verofilcon A toric soft contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: PRECISION1® for Astigmatism;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lenses