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Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.
Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kalifilcon A Daily Disposable Toric | Experimental | Kalifilcon A Daily Disposable Toric |
|
| Total1 for Astigmatism | Active Comparator | Total1 for Astigmatism |
|
| Precision1 for Astigmatism | Active Comparator | Precision1 for Astigmatism |
|
| MyDay Toric | Active Comparator | MyDay Toric |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kalifilcon Toric Lens | Device | Kalifilcon A Daily Disposable Toric for Ametropia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Gaze Orientation for 5 Minutes | Primary gaze orientation is measured in degrees using a slit lamp and reticule. | 5 minutes after lens insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb, Incorporated | Rochester | New York | 14609 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Kalifilcon A Daily Disposable Toric Compared to Total1, Precision1, and MyDay Toric. | Participants received kalifilcon A daily disposable toric, commercially available Total1 for Astigmatism, Precision1 for Astigmatism, and MyDay Toric. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Kalifilcon A Daily Disposable Toric, Total1, Precision1, and MyDay Toric. | Participants received kalifilcon A daily disposable toric, Total1 for Astigmatism, Precision1 for Astigmatism, and MyDay Toric. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Primary Gaze Orientation for 5 Minutes | Primary gaze orientation is measured in degrees using a slit lamp and reticule. | Posted | Mean | Standard Deviation | degrees | 5 minutes after lens insertion |
|
throughout study, average of 22 days
There were no Adverse Events
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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, Total1, Precision1, and MyDay Toric. | Participants received kalifilcon A daily disposable toric, commercially available Total1 for Astigmatism, Precision1 for Astigmatism, and MyDay Toric. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffery Schafer, OD, MS Director, Clinical Research | Bausch & Lomb | 585-338-5664 | jeffery.schafer@bausch.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 | Aug 9, 2023 | Oct 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Total1 for Astigmatism | Device | Total1 for Astigmatism |
|
| Precision1 for Astigmatism | Device | Precision1 for Astigmatism |
|
| MyDay Toric | Device | MyDay Toric |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Participants received Precision1 for Astigmatism
| OG003 | MyDay Toric | Participants received MyDay Toric |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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