Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.
Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRECISION1, then Biotrue | 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) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day. |
|
| Biotrue, 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) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day. |
|
| 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 |
|---|---|---|
| Least Squares Mean Distance Visual Acuity (VA) With Study Lenses | Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. | Day 8 (-0/+3 days), each study lens type |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kindred Optics at Maitland Vision | Maitland | Florida | 32751 | United States | ||
| Tallahassee Eye Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 129 enrolled, 3 subjects were screen failures prior to randomization. This reporting group includes all randomized subjects, as treated (126).
Subjects were recruited from 8 investigative sites in the US.
| ID | Title | Description |
|---|---|---|
| FG000 | PRECISION1, Then Biotrue | 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) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses was worn each day. |
| FG001 | Biotrue, Then PRECISION1 | 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) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses was worn each day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Wear Period, 8 -0/+3 Days |
| |||||||||||||
| Second Wear Period, 8 -0/+3 Days |
|
Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study, as treated.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PRECISION1, Then Biotrue | 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) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses was worn each day. |
| BG001 | Biotrue, 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 | Least Squares Mean Distance Visual Acuity (VA) With Study Lenses | Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. | Full Analysis Set: All randomized subjects who were exposed to any study lenses evaluated in this clinical study with data at Day 8. | Posted | Least Squares Mean | Standard Error | logMAR | Day 8 (-0/+3 days), each study lens type | eyes | eyes |
|
Adverse events (AEs) were collected from time of consent to study exit, up to 22 days.
AEs 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, as treated.
Not provided
| 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2021 | Mar 6, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2022 | Mar 6, 2023 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nesofilcon A contact lenses | Device | Spherical soft contact lenses for daily disposable wear |
|
|
| Tallahassee |
| Florida |
| 32308 |
| United States |
| Franklin Park Eye Center PC | Franklin Park | Illinois | 60131 | United States |
| Heart of America Eye Care | Shawnee Mission | Kansas | 66204 | United States |
| Complete Eye Care Of Medina | Medina | Minnesota | 55340 | United States |
| ProCare Vision Centers, Inc. | Granville | Ohio | 43023 | United States |
| Clarke EyeCare Center | Wichita Falls | Texas | 76308 | United States |
| Stine Eye Center | Weston | Wisconsin | 54476 | United States |
| NOT COMPLETED |
|
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) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses was worn each day. |
| 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 |
|
| OG001 | Biotrue | Nesofilcon A contact lenses worn in Period 1 or Period 2, as randomized, in both eyes during waking hours only at least 10 hours per day for -0/+3 days. A fresh pair of lenses was worn each day. |
|
|
|
| 0 |
| 126 |
| 0 |
| 126 |
| 0 |
| 126 |
| EG001 | PRECISION1 Ocular | Events reported in this group occurred while exposed to the verofilcon A contact lenses. | 0 | 252 | 0 | 252 | 0 | 252 |
| EG002 | PRECISION1 NonOcular | Events reported in this group occurred while exposed to the verofilcon A contact lenses. | 0 | 126 | 0 | 126 | 0 | 126 |
| EG003 | Biotrue Ocular | Events reported in this group occurred while exposed to the nesofilcon A contact lenses. | 0 | 252 | 0 | 252 | 0 | 252 |
| EG004 | Biotrue NonOcular | Events reported in this group occurred while exposed to the nesofilcon A contact lenses. | 0 | 126 | 0 | 126 | 0 | 126 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study,