Product Performance of a New Silicone Hydrogel Contact Lens

Study Overview
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Brief Summary
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The objective of this study is to evaluate the product performance of kalifilcon A, compared to the Johnson & Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses when worn by current soft contact lens wearers on a daily disposable wear basis.

Official Title
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A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: kalifilcon A
* Device: delefilcon A
* Device: senofilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 40 years old on the date the ICF is signed and have capacity to provide voluntary informed consent. myopic and require lens correction from -0.50 to -6.00 Diopter (D) with 0.25 D steps, in each eye. correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution [logMAR]) or better (2 meters distance, high-contrast chart) in each eye. free of any anterior segment disorders. adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks. access to internet connection and personal email to send/receive emails. habitually wear either Alcon's Air Optix Aqua, Air Optix with HydraGlyde, Air Optix Night & Day, Bausch + Lomb's PureVision 2, Bausch + Lomb ULTRA, CooperVision's Biofinity, Johnson & Johnson Acuvue Oasys® with HydraClear™, or Acuvue Vita soft contact lenses. Exclusion Criteria: participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation. have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months. have any systemic or ocular disease currently affecting ocular health in the Investigator's opinion may have an effect on ocular health during the course of the study. using any systemic, topical or topical ocular medications that will in the Investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses. refractive astigmatism of greater than 0.75 D in either eye. anisometropia (spherical equivalent) of greater than 2.00 D. amblyopic. have had any corneal surgery (e.g., refractive surgery).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kalifilcon A<br>kalifilcon A daily disposable contact lens | Device: kalifilcon A<br>* kalifilcon A daily disposable contact lens<br>|
| Active Comparator: delefilcon A<br>DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses | Device: delefilcon A<br>* DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses<br>|
| Active Comparator: senofilcon A<br>Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens | Device: senofilcon A<br>* Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in logMAR Contact Lens Visual Acuity | logMAR is the logarithm of the minim angle of resolution | Baseline, 2 Week Follow up | 
| Percentage of Participants in the Test Lens Group Agreeing With the Statement Are Comfortable Throughout the Day |  | 2 Week Follow up | 
| Percentage of Participants in the Test Lens Group Agreeing With the Statement Provide Clear Vision Throughout the Day |  | 2 Week Follow up |