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Brief summary: Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double-masked (subject and investigator), 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), 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 subjects satisfy all eligibility criteria, subjects will be dispensed study lenses according to unique randomization tables that will be provided to each Investigator. 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 |
| |
| Acuvue Oasys 1-Day for Astigmatism | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kalifilcon A Daily Disposable Toric | Device | kalifilcon A Daily Disposable Toric |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Gaze Orientation | Primary gaze orientation 5 minutes after lens insertion | Assessed 5 minutes after lens insertion |
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Inclusion Criteria:
Exclusion Criteria:
The subject is not eligible to participate in the study if the subject is:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb, Incorporated | Rochester | New York | 14609 | United States |
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30 of 30 subjects were randomized.
30 Subjects were screened for eligibility between August 11, 2023 and August 15, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Received Kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism | Participants first received kalifilcon A Daily Disposable Toric then received control lens on day of study visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Received Kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism | All 30 subjects that completed the study received both kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism |
| 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 | Primary gaze orientation 5 minutes after lens insertion | Posted | Mean | Standard Deviation | Degrees | Assessed 5 minutes after lens insertion |
|
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Assessed for approximately 30 minutes
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 | Participants Received Kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism | All 30 subjects that completed the study received both kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism |
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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 | Jul 25, 2023 | Jun 12, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Acuvue Oasys 1-Day for Astigmatism | Device | Acuvue Oasys 1-Day for Astigmatism |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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