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The objective is to evaluate the fit characteristics (primary gaze orientation, rotational recovery, and movement) of kalifilcon A daily disposable toric lenses as compared to commercially available Ultra for Astigmatism lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T01: +6.00 -2.75 x 180 | Experimental | kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
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| T02: +6.00-2.75 x 090 | Experimental | kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
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| T03: -3.00-2.75 x180 | Experimental | kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
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| T04: -3.00 -2.75 x 090 | Experimental | kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
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| T05: -9.00 -2.75 x 180 | Experimental | kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
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| T06: -9.00 -2.75 x 090 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kalifilcon A Daily Disposable Toric LD213001 Contact Lenses | Device | kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | Primary gaze orientation is measured in degrees. Measurement Description: Primary gaze is when the patient is looking straight ahead. Orientation refers to how much the contact lens is rotated on the eye. Primary gaze orientation of the contact lens is measured in degrees at the slit-lamp (microscope) using a reticle (protractor). Lens orientation was measured in primary gaze in 5-degree increments. Negative values indicate the contact lens was rotated in the temporal direction. Positive values indicate the contact lens was rotated in the nasal direction. The greater the value (positive or negative) the more the lens is rotated. The absolute value was calculated for all the measurements. The absolute values were used to calculate the mean primary gaze orientation after 3 minutes of contact lens wear. Criteria: P-values ≤0.05 will be considered statistically significant. | 3 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 are a total of 14 study lens types (8 test contact lenses and 6 comparators contact lenses). Each study lens type will be worn once for approximately 10 minutes.
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants Received Kalifilcon LD213001 Contact Lenses & Ultra for Astigmatism Contact Lenses | Participants were given a total of 14 study lens types (8 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses and 6 Commercially available Ultra for Astigmatism Contact Lenses). Each study lens type will be worn once for approximately 10 minutes. |
| 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 | Oct 8, 2021 |
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| Experimental |
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
|
| T07: -12.00 -2.75 x 180 | Experimental | kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
|
| T08: -12.00-2.75 x 090 | Experimental | kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
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| C01: +6.00 -2.75 x 180 | Active Comparator | Commercially available Ultra for Astigmatism Contact Lenses |
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| C02: +6.00-2.75 x 090 | Active Comparator | Commercially available Ultra for Astigmatism Contact Lenses |
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| C03: -3.00-2.75 x180 | Active Comparator | Commercially available Ultra for Astigmatism Contact Lenses |
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| C04: -3.00 -2.75 x 090 | Active Comparator | Commercially available Ultra for Astigmatism Contact Lenses |
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| C05: -9.00 -2.75 x 180 | Active Comparator | Commercially available Ultra for Astigmatism Contact Lenses |
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| C06: -9.00 -2.75 x 090 | Active Comparator | Commercially available Ultra for Astigmatism Contact Lenses |
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| Commercially available Ultra for Astigmatism Contact Lenses | Device | Commercially available Ultra for Astigmatism Contact Lenses at different fittings |
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| Experimental: T01: +6.00 -2.75 x 180 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
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| Experimental: T02: +6.00-2.75 x 090 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
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| Experimental: T03: -3.00-2.75 x180 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
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| Experimental: T04: -3.00 -2.75 x 090 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
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| Experimental: T05: -9.00 -2.75 x 180 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
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| Experimental: T06: -9.00 -2.75 x 090 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
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| Experimental: T07: -12.00 -2.75 x 180 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
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| Experimental: T08: -12.00-2.75 x 090 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses |
|
| C01: +6.00 -2.75 x 180 Commercially Available Ultra for Astigmatism Contact Lenses |
|
| C02: +6.00-2.75 x 090 Commercially Available Ultra for Astigmatism Contact Lenses |
|
| C03: -3.00-2.75 x180 Commercially Available Ultra for Astigmatism Contact Lenses |
|
| C04: -3.00 -2.75 x 090 Commercially Available Ultra for Astigmatism Contact Lenses |
|
| C05: -9.00 -2.75 x 180 Commercially Available Ultra for Astigmatism Contact Lenses |
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| C06: -9.00 -2.75 x 090 Commercially Available Ultra for Astigmatism Contact Lenses |
|
| COMPLETED | There are a total of 14 study lens types (8 test contact lenses and 6 comparators contact lenses). Each study lens type will be worn once for approximately 10 minutes. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Participants were given a total of 14 study lens types (8 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses and 6 Commercially available Ultra for Astigmatism Contact Lenses). Each study lens type will be worn once for approximately 10 minutes. |
| 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, Categorical | Count of Participants | Participants |
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| 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 |
| |||||||||||||||||
| Region of Enrollment | Number | 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 | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | Primary gaze orientation is measured in degrees. Measurement Description: Primary gaze is when the patient is looking straight ahead. Orientation refers to how much the contact lens is rotated on the eye. Primary gaze orientation of the contact lens is measured in degrees at the slit-lamp (microscope) using a reticle (protractor). Lens orientation was measured in primary gaze in 5-degree increments. Negative values indicate the contact lens was rotated in the temporal direction. Positive values indicate the contact lens was rotated in the nasal direction. The greater the value (positive or negative) the more the lens is rotated. The absolute value was calculated for all the measurements. The absolute values were used to calculate the mean primary gaze orientation after 3 minutes of contact lens wear. Criteria: P-values ≤0.05 will be considered statistically significant. | Measurement Description: Lens orientation (in 5-degree increments) was measured in primary gaze (nasal = +, temporal = -) | Posted | Mean | Standard Deviation | degrees | 3 minutes | Eyes | Eyes |
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through study completion, an average of 40 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 Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Participants were given a total of 14 study lens types (8 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses and 6 Commercially available Ultra for Astigmatism Contact Lenses). Each study lens type will be worn once for approximately 10 minutes. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill Schafer | Bausch + Lomb Incorporated | 0000000 | Jill.Schafer@bausch.com |
| Aug 31, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| >=65 years |
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| Title | Measurements |
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| T08 |
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