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The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.
Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DT1, then Infuse | Other | Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. |
|
| Infuse, then DT1 | Other | Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lenses | Device | Commercially available silicone hydrogel contact lenses used as indicated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Distance VA (logMAR) With Study Lenses | Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. | Day 8 (-0/+3), each study lens type |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigator 6355 | Orlando | Florida | 32803 | United States | ||
| Alcon Investigator 6418 |
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Of the 112 enrolled, one subject was exited prior to randomization as a screen failure. This reporting group includes all randomized subjects (111).
This study was conducted at 8 investigative sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | DT1, Then Infuse | Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. |
| FG001 | Infuse, Then DT1 | Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, 8 (-0/+3) Days |
| |||||||||||||
| Period 2, 8 (-0/+3) Days |
|
Full Analysis Set (FAS): All randomized subjects exposed to any study lenses evaluated in this study
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| ID | Title | Description |
|---|---|---|
| BG000 | DT1, Then Infuse | Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. |
| BG001 | Infuse, Then DT1 |
| 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 | Least Squares Mean Distance VA (logMAR) With Study Lenses | Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. | FAS with non-missing response (eye) | Posted | Least Squares Mean | Standard Error | logMAR | Day 8 (-0/+3), each study lens type | eyes | eyes |
|
Adverse events (AE's) were collected from time of consent to study exit, 16-22 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study.
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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 | Pretreatment | Events reported in this group occurred prior to exposure to the study contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Projects - CDMA Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 26, 2021 | Oct 11, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 25, 2021 | Oct 11, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Kalifilcon A contact lenses | Device | Commercially available silicone hydrogel contact lenses used as indicated |
|
|
| Tallahassee |
| Florida |
| 32308 |
| United States |
| Alcon Investigator 3950 | Bloomington | Illinois | 61704 | United States |
| Alcon Investigator 6614 | Franklin Park | Illinois | 60131 | United States |
| Alcon Investigator 6583 | Eden Prairie | Minnesota | 55344 | United States |
| Alcon Investigator 3382 | Wyomissing | Pennsylvania | 19610 | United States |
| Alcon Investigator 6353 | Memphis | Tennessee | 38111 | United States |
| Alcon Investigator 2786 | Memphis | Tennessee | 38119 | United States |
| NOT COMPLETED |
|
Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
Kalifilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 (-0/+3) days on a daily wear, daily disposable basis |
|
|
|
| 0 |
| 111 |
| 0 |
| 111 |
| 0 |
| 111 |
| EG001 | DT1 Ocular | Events reported in this group occurred while exposed to the delefilcon A contact lenses | 0 | 222 | 0 | 222 | 0 | 222 |
| EG002 | DT1 Nonocular | Events reported in this group occurred while exposed to the delefilcon A contact lenses | 0 | 111 | 0 | 111 | 0 | 111 |
| EG003 | Infuse Ocular | Events reported in this group occurred while exposed to the kalifilcon A contact lenses | 0 | 222 | 0 | 222 | 0 | 222 |
| EG004 | Infuse Nonocular | Events reported in this group occurred while exposed to the kalifilcon A contact lenses | 0 | 111 | 0 | 111 | 0 | 111 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.