Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses

Study Overview
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Brief Summary
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Approximately 20 habitual soft contact lens wearing participants will be enrolled in this unilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, subjects will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.

Official Title
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Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses

Conditions
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Habitual Soft Contact Lens Use

Intervention / Treatment
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* Device: kalifilcon A lenses
* Device: Dalies Total 1
* Device: Precision 1
* Device: Biotrue ONEday


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older and have full legal capacity to volunteer. Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. No active ocular disease or allergic conjunctivitis. Not using any topical ocular medications. Willing and able to follow instructions. Signed a statement of informed consent. Exclusion Criteria: Participating in a conflicting study in the opinion of the Investigator. Considered by the Investigator to not be a suitable candidate for participation.

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 |
| --- | --- |
| Experimental: kalifilcon A lenses<br> | Device: kalifilcon A lenses<br>* Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.<br>|
| Active Comparator: Dailies Total 1<br> | Device: Dalies Total 1<br>* Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.<br>|
| Active Comparator: Precision 1<br> | Device: Precision 1<br>* Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.<br>|
| Active Comparator: Biotrue ONEday<br> | Device: Biotrue ONEday<br>* Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface Refractive Index Shifts at 5 Minutes | Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units. | 5 minutes | 
| Surface Refractive Index Shifts at 10 Minutes | Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units. | 10 minutes | 
| Surface Refractive Index Shifts at 15 Minutes | Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units. | 15 minutes |