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This objective of this clinical study aims to confirm whether multiple kalifilcon A daily disposable toric contact lenses are providing the intended level of spherical aberration correction when worn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| kalifilcon A Daily Disposable Toric LD213001 lens | Experimental | kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D | Device | kalifilcon A Daily Disposable Toric LD213001 lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Spherical Aberration Measurement | Spherical aberration (SA) occurs when light rays entering at different points of a spherical lens are not focused to the same point of the optical axis. | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Visibility of Toric Etch Mark by the Investigator | Number of lenses the investigator could identify the toric etch mark | 60 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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| ID | Title | Description |
|---|---|---|
| FG000 | Kalifilcon A Daily Disposable Toric LD213001 Lens | kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D: kalifilcon A Daily Disposable Toric LD213001 lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Kalifilcon A Daily Disposable Toric LD213001 Lens | kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D: kalifilcon A Daily Disposable Toric LD213001 lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Spherical Aberration Measurement | Spherical aberration (SA) occurs when light rays entering at different points of a spherical lens are not focused to the same point of the optical axis. | 30 eyes wore the +3D, 0D, -3D, -6D, and -9D contact lenses. 26 eyes wore the +6D contact lenses. | Posted | Mean | Standard Deviation | microns | 60 minutes | Lenses | Lenses |
|
60 minutes
Occular Adverse Event
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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 | Kalifilcon A Daily Disposable Toric LD213001 Lens | kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D: kalifilcon A Daily Disposable Toric LD213001 lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steffen Robert, Senior Director Clinical Affairs | Bausch + Lomb Incorporated | 15853386399 | robert.steffen@bauschcloud.com |
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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 | Jul 29, 2021 | Mar 8, 2023 | Prot_SAP_001.pdf |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Lenses |
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| Secondary | Visibility of Toric Etch Mark by the Investigator | Number of lenses the investigator could identify the toric etch mark | 30 eyes wore the +3D, 0D, -3D, -6D, and -9D contact lenses. 26 eyes wore the +6D contact lenses. | Posted | Number | Lenses | 60 minutes | Lenses | Lenses |
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|
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| 0 |
| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
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| Title | Measurements |
|---|---|
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| T04 kali -3D |
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| T05 kali -6D |
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| T06 kali -9D |
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