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The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.
Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOTAL30, then Biofinity | Other | Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection. |
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| Biofinity, then TOTAL30 | Other | Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lehfilcon A contact lenses | Device | Investigational silicone hydrogel contact lenses |
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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 30, each study product |
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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 257 enrolled, 8 subjects were exited prior to randomization as screen failures. This reporting group includes all subjects exposed to the study lenses, as treated (249). Note: One subject randomized to TOTAL30, then Biofinity was exposed to the incorrect study lenses in the sequence (Biofinity, then TOTAL30).
This study was conducted at 14 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | TOTAL30, Then Biofinity | Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Approximately 30 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 28, 2021 | Nov 16, 2022 |
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| Comfilcon A contact lenses | Device | Commercially available silicone hydrogel contact lenses |
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| CLEAR CARE | Device | Hydrogen peroxide-based cleaning and disinfecting solution |
|
| Oakland |
| California |
| 94607 |
| United States |
| Alcon Investigator 8106 | San Francisco | California | 94127 | United States |
| Alcon Investigator 6356 | Longwood | Florida | 32779 | United States |
| Alcon Investigator 6565 | Maitland | Florida | 32751 | United States |
| Alcon Investigator 6654 | West Palm Beach | Florida | 33405 | United States |
| Alcon Investigator 6567 | Pittsburg | Kansas | 66762 | United States |
| Alcon Investigator 5582 | Louisville | Kentucky | 40206 | United States |
| Alcon Investigator 8097 | Sterling Heights | Michigan | 48312 | United States |
| Alcon Investigator 7980 | Willmar | Minnesota | 56201 | United States |
| Alcon Investigator 8130 | New York | New York | 10036 | United States |
| Alcon Investigator 6401 | Warwick | Rhode Island | 02888 | United States |
| Alcon Investigator 6353 | Memphis | Tennessee | 38111 | United States |
| Alcon Investigator 8175 | Austin | Texas | 78731 | United States |
| Biofinity, Then TOTAL30 |
Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 (Approximately 30 Days) |
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All subjects exposed to any study lenses evaluated in this study, as randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | TOTAL30, Then Biofinity | Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection. |
| BG001 | Biofinity, Then TOTAL30 | Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection. |
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All subjects exposed to any study lenses evaluated in this study, as randomized, with non-missing response (eye) | Posted | Least Squares Mean | Standard Error | logMAR | Day 30, each study product | eyes | eyes |
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Adverse events (AE's) were collected from time of consent to study exit, approximately 65 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 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 | 249 | 0 | 249 | 0 | 249 |
| EG001 | TOTAL30 Ocular | Events reported in this group occurred while exposed to the lehfilcon A contact lenses | 0 | 490 | 0 | 490 | 0 | 490 |
| EG002 | TOTAL30 Nonocular | Events reported in this group occurred while exposed to the lehfilcon A contact lenses | 0 | 245 | 2 | 245 | 0 | 245 |
| EG003 | Biofinity Ocular | Events reported in this group occurred while exposed to the comfilcon A contact lenses | 0 | 492 | 0 | 492 | 0 | 492 |
| EG004 | Biofinity Nonocular | Events reported in this group occurred while exposed to the comfilcon A contact lenses | 0 | 246 | 0 | 246 | 0 | 246 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypotension | Vascular 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 | |
|---|---|---|---|---|
| CDMA 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 | Jul 29, 2021 | Nov 16, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| 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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