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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| kalifilcon A lenses | Experimental |
| |
| Dailies Total 1 | Active Comparator |
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| Precision 1 | Active Comparator |
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| Biotrue ONEday | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kalifilcon A lenses | Device | Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery Schafer, OD | Bausch & Lomb Incorporated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch and Lomb Site 01 | Rochester | New York | 14609 | United States |
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There were 10 participants. Each of the 10 participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. All participants completed the study. All 10 participants completed kalifilcon A lens wear, all 10 participants completing Dailies Total 1 wear, all 10 participants completed Precision 1 wear, and all 10 participants completed Biotrue ONEday wear. There were 10 participants total who wore each lens type for 5, 10 and 15 minutes each. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2020 |
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| Dalies Total 1 | Device | Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint. |
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| Precision 1 | Device | Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint. |
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| Biotrue ONEday | Device | Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint. |
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| COMPLETED |
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| NOT COMPLETED |
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Subjects wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. All participants completed the study, therefore each participant wore kalifilcon A lens, Dailies Total 1, Precision 1, and Biotrue ONEday. The only way to show demography for each lens is to show the same information for 10 participants that completed kalifilcon A lens wear, the 10 participants that completed Dailies Total 1 wear, the 10 participants that completed Precision 1 wear, and the 10 participants that completed Biotrue ONEday wear, but there are 10 participants total, not the 40 that the demography table would show if the duplicate information is entered for each lens to which a participant was exposed. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. The surface refractive index was measured at each timepoint. All participants completed the study. All 10 participants completed kalifilcon A lens wear, all 10 participants completing Dailies Total 1 wear, all 10 participants completed Precision 1 wear, and all 10 participants completed Biotrue ONEday wear. There were 10 participants total who wore each lens type for 5, 10 and 15 minutes each. | Posted | Mean | Standard Deviation | No units | 5 minutes |
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| Primary | 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. | Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. The surface refractive index was measured at each timepoint. All participants completed the study. All 10 participants completed kalifilcon A lens wear, all 10 participants completing Dailies Total 1 wear, all 10 participants completed Precision 1 wear, and all 10 participants completed Biotrue ONEday wear. There were 10 participants total who wore each lens type for 5, 10 and 15 minutes each. | Posted | Mean | Standard Deviation | No units | 10 minutes |
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| Primary | 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. | Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. The surface refractive index was measured at each timepoint. All participants completed the study. All 10 participants completed kalifilcon A lens wear, all 10 participants completing Dailies Total 1 wear, all 10 participants completed Precision 1 wear, and all 10 participants completed Biotrue ONEday wear. There were 10 participants total who wore each lens type for 5, 10 and 15 minutes each. | Posted | Mean | Standard Deviation | No units | 15 minutes |
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4 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. All participants completed the study. All 10 participants completed kalifilcon A lens wear, all 10 participants completing Dailies Total 1 wear, all 10 participants completed Precision 1 wear, and all 10 participants completed Biotrue ONEday wear. There were 10 participants total who wore each lens type for 5, 10 and 15 minutes each. There are were 0 adverse events total in the 10 participants, therefore there were 0 AEs while each participant wore kalifilcon A lens, 0 AEs while each participant wore Dailies Total 1, 0 AEs while each participant wore Precision 1, and 0 AEs while each participant wore Biotrue ONEday. The same is true for serious AEs. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch & Lomb | 5853386399 | robert.steffen@bausch.com |
| Aug 18, 2021 |
| Prot_SAP_000.pdf |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Precision 1: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint. |
| OG003 | Biotrue ONEday | Biotrue ONEday: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint. |
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Precision 1: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint. |
| OG003 | Biotrue ONEday | Biotrue ONEday: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint. |
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