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The purpose of this study is to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.
Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. The total duration of subject participation will be up to 22 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P1fA, then AMfA | Other | Verofilcon A toric contact lenses worn first, with etafilcon A toric 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. |
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| AMfA, then P1fA | Other | Etafilcon A toric contact lenses worn first, with verofilcon A toric 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verofilcon A toric contact lenses | Device | Soft contact lenses for optical correction of astigmatism |
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| 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 days), each study lens type |
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Inclusion Criteria:
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 8135 | Los Angeles | California | 90012 | United States | ||
| Alcon Investigator 8062 |
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Of the 115 enrolled, 1 participant was exited from the study prior to randomization as a screen failure. This reporting group includes all subjects/eyes exposed to any study lenses evaluated in this study (114).
Study participants were recruited from 8 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | P1fA, Then AMfA | Verofilcon A toric contact lenses worn first, with etafilcon A toric 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 | AMfA, 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 | Jun 1, 2021 | Aug 22, 2022 |
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Subjects will receive treatment based upon the randomized treatment sequence assignment.
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| Etafilcon A toric contact lenses | Device | Soft contact lenses for optical correction of astigmatism |
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|
| Oakland |
| California |
| 94607 |
| United States |
| Alcon Investigator 6355 | Orlando | Florida | 32803 | United States |
| Alcon Investigator 6614 | Franklin Park | Illinois | 60131 | United States |
| Alcon Investigator 6645 | Shawnee Mission | Kansas | 66204 | 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 |
Etafilcon A toric contact lenses worn first, with verofilcon A toric 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. |
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| NOT COMPLETED |
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| 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 | P1fA, Then AMfA | Verofilcon A toric contact lenses worn first, with etafilcon A toric 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 | AMfA, Then P1fA | Etafilcon A toric contact lenses worn first, with verofilcon A toric 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 |
| 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 (NIH/OMB) | 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 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. | Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study with non-missing response | Posted | Least Squares Mean | Standard Error | logMAR | Day 8 (-0/+3 days), each study lens type | eyes | eyes |
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Adverse events (AE's) were collected from time of consent to study exit, approximately 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. 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 | 0 | 114 | 0 | 114 | 0 | 114 |
| EG001 | P1fA Ocular | Events reported in this group occurred while exposed to the verofilcon A toric contact lenses | 0 | 228 | 0 | 228 | 0 | 228 |
| EG002 | P1fA Nonocular | Events reported in this group occurred while exposed to the verofilcon A toric contact lenses | 0 | 114 | 1 | 114 | 0 | 114 |
| EG003 | AMfA Ocular | Events reported in this group occurred while exposed to the etafilcon A toric contact lenses | 0 | 226 | 0 | 226 | 0 | 226 |
| EG004 | AMfA Nonocular | Events reported in this group occurred while exposed to the etafilcon A toric contact lenses | 0 | 113 | 0 | 113 | 0 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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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 | |
|---|---|---|---|---|
| Sr. Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2021 | Aug 22, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D001251 | Astigmatism |
| 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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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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