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The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.
Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRECISION1, then Biotrue ONEday | Other | Verofilcon A contact lenses worn first, with nesofilcon 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. |
|
| Biotrue ONEday, then PRECISION1 | Other | Nesofilcon 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 | Spherical soft contact lenses for daily disposable wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity (VA) With Study Lenses | Distance 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 formal hypothesis was predefined for the primary endpoint. No inferential testing was performed. | Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CDMA Project 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 6402 |
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Of the 56 subjects enrolled in the study, 1 subject was discontinued after randomization and prior to exposure to the study lenses. This reporting group includes all randomized and exposed subjects (55).
Subjects were recruited from 4 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | PRECISION1, Then Biotrue ONEday | Verofilcon A contact lenses worn first, with nesofilcon 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 | Biotrue ONEday, Then PRECISION1 | Nesofilcon 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 Biotrue ONEday | Verofilcon A contact lenses worn first, with nesofilcon 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 | Biotrue ONEday, 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 Visual Acuity (VA) With Study Lenses | Distance 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 formal hypothesis was predefined for the primary endpoint. No inferential testing was performed. | Safety Analysis Set with non-missing response | Posted | Mean | Standard Deviation | logMAR | Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type | eyes | eyes |
|
Adverse events (AE's) were collected from time of consent to study exit, up to 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 participants. 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 | |
|---|---|---|---|---|
| CDMA 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 | Aug 13, 2020 | Sep 22, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2020 | Sep 22, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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|
| Nesofilcon A contact lenses | Device | Spherical soft contact lenses for daily disposable wear |
|
|
| Medina |
| Minnesota |
| 55340 |
| United States |
| Alcon Investigator 6313 | Powell | Ohio | 43065 | United States |
| Alcon Investigator 8028 | Wichita Falls | Texas | 76308 | United States |
| NOT COMPLETED |
|
Nesofilcon 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 |
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| 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 |
| Biotrue ONEday |
Nesofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -0/+3 days in a daily disposable modality |
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | PRECISION1 Ocular | Events reported in this group occurred while exposed to the verofilcon A contact lenses | 0 | 110 | 0 | 110 | 0 | 110 |
| EG002 | PRECISION1 Nonocular | Events reported in this group occurred while exposed to the verofilcon A contact lenses | 0 | 55 | 0 | 55 | 0 | 55 |
| EG003 | Biotrue ONEday Ocular | Events reported in this group occurred while exposed to the nesofilcon A contact lenses | 0 | 108 | 0 | 108 | 0 | 108 |
| EG004 | Biotrue ONEday Nonocular | Events reported in this group occurred while exposed to the nesofilcon A contact lenses | 0 | 54 | 0 | 54 | 0 | 54 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.