Clinical Performance of Two Commercial, Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.

Detailed Description
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Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.

Official Title
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Clinical Performance of Two Commercial, Daily Disposable Contact Lenses

Conditions
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Refractive Errors, Ametropia, Myopia

Intervention / Treatment
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* Device: Delefilcon A contact lenses
* Device: Kalifilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day; At least 3 months of contact lens wearing experience; Less than or equal to 0.75 diopter (D) astigmatism in each eye; Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer; Monovision and/or multifocal lens wearer; Routinely sleeps in habitual contact lenses. 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: DT1, then Infuse<br>Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. | Device: Delefilcon A contact lenses<br>* Commercially available silicone hydrogel contact lenses used as indicated<br>* Other names: DT1;Device: Kalifilcon A contact lenses<br>* Commercially available silicone hydrogel contact lenses used as indicated<br>* Other names: Infuse;|
| Other: Infuse, then DT1<br>Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. | Device: Delefilcon A contact lenses<br>* Commercially available silicone hydrogel contact lenses used as indicated<br>* Other names: DT1;Device: Kalifilcon A contact lenses<br>* Commercially available silicone hydrogel contact lenses used as indicated<br>* Other names: Infuse;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Mean Distance VA (logMAR) With Study Lenses | Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. | Day 8 (-0/+3), each study lens type | 

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