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The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.
The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision1, then Infuse | Other | Verofilcon 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 in a daily disposable modality. |
|
| Infuse, then Precision1 | Other | Kalifilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verofilcon A contact lenses | Device | Commercially available silicone hydrogel contact lenses for daily disposable wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. No inferential testing was pre-specified for this endpoint. | Day 8 (-0/+3 days), 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 6565 | Maitland | Florida | 32751 | United States | ||
| Alcon Investigator 6355 |
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This reporting group includes all subjects/eyes exposed to any study lenses evaluated in this study.
Study participants were recruited from 4 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | Precision1, Then Infuse | Verofilcon 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 in a daily disposable modality. |
| FG001 | Infuse, Then Precision1 | Kalifilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Wear Period (8 -0/+3 Days) |
|
| |||||||||||||||||||||
| Second Wear Period (8 -0/+3 Days) |
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Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Precision1, Then Infuse | Verofilcon 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 in a daily disposable modality. |
| BG001 | Infuse, Then Precision1 |
| 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 | 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. No inferential testing was pre-specified for this endpoint. | Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study with non-missing response | Posted | Mean | Standard Deviation | logMAR | Day 8 (-0/+3 days), each study lens type | eyes | eyes |
|
Adverse events (AE's) were collected from time of consent to study exit, approximately 24 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 participants. The safety analysis set 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 | |
|---|---|---|---|---|
| Sr. Project Lead, 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 | Jun 22, 2021 | Aug 13, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 24, 2021 | Aug 13, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Subjects will receive treatment based upon the randomized treatment sequence assignment
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|
| Kalifilcon A contact lenses | Device | Commercially available silicone hydrogel contact lenses for daily disposable wear |
|
|
| Orlando |
| Florida |
| 32803 |
| United States |
| Alcon Investigator 6583 | Eden Prairie | Minnesota | 55344 | United States |
| Alcon Investigator 6313 | Powell | Ohio | 43065 | United States |
| NOT COMPLETED |
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Kalifilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Infuse | Kalifilcon A contact lenses worn bilaterally (in both eyes) during the first wear period or the second wear period, as randomized, for 8 -0/+3 days in a daily disposable modality. |
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Precision1 Ocular | Events reported in this group occurred while exposed to the Precision1 contact lenses | 0 | 116 | 0 | 116 | 0 | 116 |
| EG002 | Precision1 Nonocular | Events reported in this group occurred while exposed to the Precision1 contact lenses | 0 | 58 | 0 | 58 | 0 | 58 |
| EG003 | Infuse Ocular | Events reported in this group occurred while exposed to the Infuse contact lenses | 0 | 120 | 0 | 120 | 0 | 120 |
| EG004 | Infuse Nonocular | Events reported in this group occurred while exposed to the Infuse contact lenses | 0 | 60 | 0 | 60 | 0 | 60 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.