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The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).
Study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. Participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. The total duration of an individual's participation in the study will be up to 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P1fA, then MDT | Other | Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use. |
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| MDT, then P1fA | Other | Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verofilcon A toric soft contact lenses | Device | Soft contact lenses for optical correction of ametropia and astigmatism |
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| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Means Distance Visual Acuity With Study Lenses at Week 1 | 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. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. | Day 8 of each study lens type worn during the corresponding crossover period |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurata Eyecare Center | Los Angeles | California | 90012 | United States | ||
| Sabal Eye Care |
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Of the 153 enrolled, 1 participant was exited prior to randomization as a screen failure. This reporting group includes all randomized participants (152).
Participants were recruited from 11 investigative sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | P1fA, Then MDT | Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type was worn for 8 (-0/+3) days for at least 10 hours per day. Lenses were removed nightly and disposed of after a single use. |
| FG001 | MDT, Then P1fA |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Wear Period, 8 (-0/+3) Days |
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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 | Jul 20, 2022 | Sep 29, 2023 |
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| Stenfilcon A toric soft contact lenses | Device | Soft contact lenses for optical correction of ametropia and astigmatism |
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| Longwood |
| Florida |
| 32779 |
| United States |
| Drs. Giedd, P.A. | Maitland | Florida | 32751 | United States |
| Vision Health Institute | Orlando | Florida | 32803 | United States |
| Franklin Park Eye Center | Franklin Park | Illinois | 60131 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Heart of America Eye Care, P.A. | Shawnee Mission | Kansas | 66204 | United States |
| Wesley Optometric Consulting | Medina | Minnesota | 55340 | United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type was worn for 8 (-0/+3) days for at least 10 hours per day. Lenses were removed nightly and disposed of after a single use. |
| COMPLETED |
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| NOT COMPLETED |
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| Second Wear Period, 8 (-0/+3) Days |
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Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | P1fA, Then MDT | Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type was worn for 8 (-0/+3) days for at least 10 hours per day. Lenses were removed nightly and disposed of after a single use. |
| BG001 | MDT, Then P1fA | Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type was worn for 8 (-0/+3) days for at least 10 hours per day. Lenses were removed nightly and disposed of after a single use. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| 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/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Least Squares Means Distance Visual Acuity With Study Lenses at Week 1 | 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. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. | Full Analysis Set with data at visit. | Posted | Least Squares Mean | Standard Error | logMAR | Day 8 of each study lens type worn during the corresponding crossover period | eyes | eyes |
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Adverse events (AEs) were collected from time of consent to study exit, up to 28 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 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. | 0 | 152 | 0 | 152 | 0 | 152 |
| EG001 | P1fA Ocular | Events reported in this group occurred while exposed to the verofilcon A contact lenses. | 0 | 304 | 0 | 304 | 0 | 304 |
| EG002 | P1fA Non-Ocular | Events reported in this group occurred while exposed to the verofilcon A contact lenses. | 0 | 152 | 0 | 152 | 0 | 152 |
| EG003 | MDT Ocular | Events reported in this group occurred while exposed to the stenfilcon A contact lenses. | 0 | 302 | 0 | 302 | 0 | 302 |
| EG004 | MDT Non-Ocular | Events reported in this group occurred while exposed to the stenfilcon A contact lenses. | 0 | 151 | 0 | 151 | 0 | 151 |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, CRD Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2022 | Sep 29, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| American Indian or Alaska Native |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| Multi-Racial |
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Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.