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The purpose of this study is to assess the clinical performance of TOTAL30 for Astigmatism (T30fA) soft contact lenses with Biofinity Toric soft contact lenses.
Subjects will be expected to attend 5 office visits and will be dispensed study lenses (per randomization sequence) for 30-day duration of bilateral wear with each study lens (approximately 60 days of lens wear). The total duration of the subject's participation in the study will be approximately 74 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T30fA, then Biofinity Toric | Other | Lehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days [-1/+3] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning & Disinfecting Solution. |
|
| Biofinity Toric, then T30fA | Other | Comfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days [-1/+3] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning & Disinfecting Solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lehfilcon A toric contact lenses | Device | Commercially available soft contact lenses worn as indicated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Distance Visual Acuity With Study Lenses at Day 30 | Visual Acuity (VA) was assessed for each eye individually with study lenses in place while reading letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with lower logMAR values representing better eyesight. | Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment. |
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Key Inclusion Criteria:
Key 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 |
|---|---|---|---|---|---|---|
| Kurata Eye Care Center | Los Angeles | California | 90012 | United States | ||
| Elsa Pao, OD |
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Of the 67 enrolled, 1 participant was discontinued following randomization but prior to exposure to the study lenses. This reporting group includes all participants exposed to any study lenses evaluated in this study (66).
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| ID | Title | Description |
|---|---|---|
| FG000 | T30fA, Then Biofinity Toric | Lehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days [-1/+3] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning & Disinfecting Solution. |
| FG001 | Biofinity Toric, Then T30fA | Comfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days [-1/+3] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning & Disinfecting Solution. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Wear Period (Approx. 30 Days) |
| |||||||||||||
| Second Wear Period (Approx. 30 Days) |
|
Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | T30fA, Then Biofinity Toric | Lehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days [-1/+3] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning & Disinfecting Solution. |
| 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 | Mean Distance Visual Acuity With Study Lenses at Day 30 | Visual Acuity (VA) was assessed for each eye individually with study lenses in place while reading letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with lower logMAR values representing better eyesight. | Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study with non-missing response. Note, One subject in the Biofinity Toric arm lost a lens on the way to the visit. Hence, the assessment was taken on 1 eye only. | Posted | Mean | Standard Deviation | logMAR | Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment. | eyes | eyes |
|
Adverse Events (AEs) were collected from time of consent to study exit, up to 74 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 before exposure to study lenses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Project Lead, 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 | Dec 15, 2023 | May 6, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2024 | May 6, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D001251 | Astigmatism |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Comfilcon A toric contact lenses | Device | Commercially available soft contact lenses) worn as indicated |
|
|
| CLEAR CARE | Device | Commercially available hydrogen peroxide-based solution for daily cleaning and disinfection of contact lenses used as indicated |
|
|
| Oakland |
| California |
| 94607 |
| United States |
| Pacific Rims Optometry | San Francisco | California | 94127 | United States |
| Vision Health Institute | Orlando | Florida | 32803 | United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| NOT COMPLETED |
|
| BG001 | Biofinity Toric, Then T30fA | Comfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days [-1/+3] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning & Disinfecting Solution. |
| 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 |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 | Biofinity Toric | Comfilcon A toric contact lenses worn in Period 1 and worn in Period 2, as randomized. |
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | T30fA Ocular | Events reported in this group occurred while exposed to lehfilcon A toric contact lenses. | 0 | 132 | 0 | 132 | 0 | 132 |
| EG002 | T30fA Nonocular | Events reported in this group occurred while exposed to lehfilcon A toric contact lenses. | 0 | 66 | 0 | 66 | 0 | 66 |
| EG003 | Biofinity Toric Ocular | Events reported in this group occurred while exposed to comfilcon A toric contact lenses. | 0 | 132 | 0 | 132 | 0 | 132 |
| EG004 | Biofinity Toric Nonocular | Events reported in this group occurred while exposed to comfilcon A toric contact lenses. | 0 | 66 | 0 | 66 | 0 | 66 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.