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The objective of this study is to evaluate the product performance of kalifilcon A, compared to the Johnson & Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses when worn by current soft contact lens wearers on a daily disposable wear basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| kalifilcon A | Experimental | kalifilcon A daily disposable contact lens |
|
| delefilcon A | Active Comparator | DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses |
|
| senofilcon A | Active Comparator | Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kalifilcon A | Device | kalifilcon A daily disposable contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in logMAR Contact Lens Visual Acuity | logMAR is the logarithm of the minim angle of resolution | Baseline, 2 Week Follow up |
| Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day" | 2 Week Follow up | |
| Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day" | 2 Week Follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Steffen | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch Site 433 | Birmingham | Alabama | 35216 | United States | ||
| Bausch Site 431 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Kalifilcon A | kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens |
| FG001 | Delefilcon A | DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses |
| 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 | Jun 28, 2019 |
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| delefilcon A |
| Device |
DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses |
|
| senofilcon A | Device | Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens |
|
| Scottsdale |
| Arizona |
| 85254 |
| United States |
| Bausch Site 406 | Azusa | California | 91702 | United States |
| Bausch Site 430 | Los Angeles | California | 90013 | United States |
| Bausch Site 419 | San Diego | California | 92123 | United States |
| Bausch Site 435 | San Francisco | California | 94112 | United States |
| Bausch Site 432 | Sunnyvale | California | 94087 | United States |
| Bausch Site 409 | Torrance | California | 90503 | United States |
| Bausch Site 416 | Denver | Colorado | 80246 | United States |
| Bausch Site 415 | Jacksonville | Florida | 32256 | United States |
| Bausch Site 434 | Jacksonville | Florida | 32256 | United States |
| Bausch Site 405 | Sarasota | Florida | 34237 | United States |
| Bausch Site 412 | Decatur | Georgia | 30035 | United States |
| Bausch Site 437 | Honolulu | Hawaii | 96814 | United States |
| Bausch Site 401 | ‘Aiea | Hawaii | 96701 | United States |
| Bausch Site 414 | Leavenworth | Kansas | 66048 | United States |
| Bausch Site 413 | Portland | Maine | 04101 | United States |
| Bausch Site 421 | Sterling Heights | Michigan | 48312 | United States |
| Bausch Site 429 | Edina | Minnesota | 55436 | United States |
| Bausch Site 422 | Raytown | Missouri | 64133 | United States |
| Bausch Site 407 | St Louis | Missouri | 63144 | United States |
| Bausch Site 418 | Warrensburg | Missouri | 64093 | United States |
| Bausch Site 424 | Jamestown | New York | 14701 | United States |
| Bausch Site 403 | Vestal | New York | 13850 | United States |
| Bausch Site 417 | Raleigh | North Carolina | 27603 | United States |
| Bausch Site 411 | Fargo | North Dakota | 58103 | United States |
| Bausch Site 423 | Miamisburg | Ohio | 45342 | United States |
| Bausch Site 425 | West Chester | Ohio | 45069 | United States |
| Bausch Site 428 | Grants Pass | Oregon | 97526 | United States |
| Bausch Site 420 | State College | Pennsylvania | 16801 | United States |
| Bausch Site 427 | Warwick | Rhode Island | 02888 | United States |
| Bausch 410 | Brentwood | Tennessee | 37027 | United States |
| Bausch Site 408 | Memphis | Tennessee | 33119 | United States |
| Bausch Site 404 | Nashville | Tennessee | 37205 | United States |
| Bausch Site 426 | League City | Texas | 77573 | United States |
| FG002 | Senofilcon A | Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Kalifilcon A | kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens |
| BG001 | Delefilcon A | DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses |
| BG002 | Senofilcon A | Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Mean Change in logMAR Contact Lens Visual Acuity | logMAR is the logarithm of the minim angle of resolution | Posted | Mean | Standard Deviation | logMAR | Baseline, 2 Week Follow up | eyes | eyes |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day" | Participants with 2 week follow up and responded to the question. | Posted | Count of Participants | Participants | 2 Week Follow up |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day" | Participants with 2 week follow up and responded to the question. | Posted | Count of Participants | Participants | 2 Week Follow up |
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2 weeks
Adverse events occurring after signing of informed consent and through the participant's end of participation in the study were reported.
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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 | kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens | 0 | 398 | 0 | 398 | 0 | 398 |
| EG001 | Delefilcon A | DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses | 0 | 202 | 0 | 202 | 0 | 202 |
| EG002 | Senofilcon A | Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens | 0 | 205 | 0 | 205 | 0 | 205 |
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Please contact sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Donatello | Bausch & Lomb | 5853385306 | Daniel.Donatello@bausch.com |
| May 26, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Male |
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| Asian |
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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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