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The purpose of this study is to compare the clinical performance of PRECISION1™ contact lenses to Clariti® 1 day contact lenses.
Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. The total duration of subject participation will be up to 22 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRECISION1, then Clariti 1-Day | Other | Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality. |
|
| Clariti 1-Day, then PRECISION1 | Other | Somofilcon 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 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 |
|---|---|---|
| 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, each study lens type |
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Key Inclusion Criteria
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CDMA Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigator 8106 | San Francisco | California | 94127 | United States | ||
| Alcon Investigator 6565 |
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Of the 170 enrolled, 3 subjects were exited prior to randomization as screen failures. This reporting group includes all randomized subjects (167).
This study was conducted at 8 investigative sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | PRECISION1, Then Clariti 1-Day | Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 days in a daily disposable modality. |
| FG001 | Clariti 1-Day, Then PRECISION1 | Somofilcon 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 days in a daily disposable modality. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Wear Period (8 Days) |
|
| |||||||||||||||||||||
| Second Wear Period (8 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 | PRECISION1, Then Clariti 1-Day | Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 days in a daily disposable modality. |
| BG001 | Clariti 1-Day, 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 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 (eye) | Posted | Least Squares Mean | Standard Error | logMAR | Day 8, 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. Note: One subject (2 eyes) wore PRECISION1 in both periods and did not wear Clariti 1-Day.
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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, CDMA 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 | Apr 10, 2021 | Jun 1, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 4, 2021 | Jun 1, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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|
| Somofilcon A contact lenses | Device | Spherical soft contact lenses for daily disposable wear |
|
|
| Maitland |
| Florida |
| 32751 |
| United States |
| Alcon Investigator 6418 | Tallahassee | Florida | 32308 | United States |
| Alcon Investigator 6614 | Franklin Park | Illinois | 60131 | United States |
| Alcon Investigator 6645 | Shawnee Mission | Kansas | 66204 | United States |
| Alcon Investigator 6402 | Medina | Minnesota | 55340 | United States |
| Alcon Investigator 8046 | Granville | Ohio | 43023 | United States |
| Alcon Investigator 8028 | Wichita Falls | Texas | 76308 | United States |
| NOT COMPLETED |
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|
Somofilcon 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 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 |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
|
| Clariti 1-Day |
Somofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 days in a daily disposable modality |
|
|
|
| 0 |
| 167 |
| 0 |
| 167 |
| 0 |
| 167 |
| EG001 | PRECISION1 Ocular | Events reported in this group occurred while exposed to the verofilcon A contact lenses | 0 | 334 | 0 | 334 | 0 | 334 |
| EG002 | PRECISION1 Systemic | Events reported in this group occurred while exposed to the verofilcon A contact lenses | 0 | 167 | 0 | 167 | 0 | 167 |
| EG003 | Clariti 1-Day Ocular | Events reported in this group occurred while exposed to the somofilcon A contact lenses | 0 | 332 | 0 | 332 | 0 | 332 |
| EG004 | Clariti 1-Day Systemic | Events reported in this group occurred while exposed to the somofilcon A contact lenses | 0 | 166 | 0 | 166 | 0 | 166 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.