Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens

Study Overview
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Brief Summary
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The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.

Detailed Description
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Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.

Official Title
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Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens

Conditions
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Refractive Errors, Astigmatism

Intervention / Treatment
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* Device: Lehfilcon A toric contact lenses
* Device: Comfilcon A toric contact lenses
* Device: CLEAR CARE


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Successful wearers of weekly/monthly 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; Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 20/25 Snellen in each eye. Able to wear contact lenses within the range of available sphere & cylinder power and axes. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Daily disposable contact lens wearers. Monovision and multifocal contact lens wearers. Habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 months prior to consent. 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: LID205255 Toric, then Biofinity Toric<br>Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. | Device: Lehfilcon A toric contact lenses<br>* FDA-cleared silicone hydrogel toric contact lenses used as indicated<br>* Other names: LID205255 Toric;Device: Comfilcon A toric contact lenses<br>* Commercially available silicone hydrogel toric contact lenses used as indicated<br>* Other names: CooperVision® Biofinity® Toric;Device: CLEAR CARE<br>* Hydrogen peroxide-based contact lens cleaning and disinfecting solution<br>|
| Other: Biofinity Toric, then LID205255 Toric<br>Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. | Device: Lehfilcon A toric contact lenses<br>* FDA-cleared silicone hydrogel toric contact lenses used as indicated<br>* Other names: LID205255 Toric;Device: Comfilcon A toric contact lenses<br>* Commercially available silicone hydrogel toric contact lenses used as indicated<br>* Other names: CooperVision® Biofinity® Toric;Device: CLEAR CARE<br>* Hydrogen peroxide-based contact lens cleaning and disinfecting solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity (VA) With Study Lenses | Visual acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed. | Day 1 and Day 30, each wear period (approximately 30 days) | 

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