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The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.
Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID205255 Toric, then Biofinity Toric | Other | Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. |
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| Biofinity Toric, then LID205255 Toric | Other | Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lehfilcon A toric contact lenses | Device | FDA-cleared silicone hydrogel toric contact lenses used as indicated |
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| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity (VA) With Study Lenses | Visual acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed. | Day 1 and Day 30, each wear period (approximately 30 days) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, CRD Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sabal Eye Care | Longwood | Florida | 32779 | United States | ||
| Drs. Giedd, P.A. |
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Of the 76 subjects enrolled in the study (i.e., signed informed consent), 2 subjects were exited prior to randomization as screen failures, and 1 randomized subject withdrew prior to exposure to the study lenses. This reporting group includes all randomized subjects/eyes (74/148).
Participants were recruited from 7 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | LID205255 Toric, Then Biofinity Toric | Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE was used for nightly contact lens cleaning and disinfection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Wear Period (Approx 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 | Jan 28, 2022 | Jun 2, 2023 |
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| Comfilcon A toric contact lenses | Device | Commercially available silicone hydrogel toric contact lenses used as indicated |
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| CLEAR CARE | Device | Hydrogen peroxide-based contact lens cleaning and disinfecting solution |
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| Maitland |
| Florida |
| 32751 |
| United States |
| Vision Health Institute | Orlando | Florida | 32803 | United States |
| Kannarr Eye Care LLC | Pittsburg | Kansas | 66762 | United States |
| Fischer Laser Eye Center | Willmar | Minnesota | 56201 | United States |
| SUNY College of Optometry Clinical Vision Research Center | New York | New York | 10036 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| FG001 | Biofinity Toric, Then LID205255 Toric | Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE was used for nightly contact lens cleaning and disinfection. |
| Exposed to Study Lenses |
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| COMPLETED |
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| NOT COMPLETED |
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| Second Wear Period (Approx 30 Days) |
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This analysis population includes all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | LID205255 Toric, Then Biofinity Toric | Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE was used for nightly contact lens cleaning and disinfection. |
| BG001 | Biofinity Toric, Then LID205255 Toric | Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE was used for nightly contact lens 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 | year |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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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 | Distance Visual Acuity (VA) With Study Lenses | Visual acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed. | All subjects exposed to any study lenses evaluated in this study, as randomized, with non-missing data at the respective visit. | Posted | Mean | Standard Deviation | logMAR | Day 1 and Day 30, each wear period (approximately 30 days) | eyes | eyes |
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Adverse events (AE's) were collected from time of consent to study exit, approximately 60 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 | 73 | 0 | 73 | 0 | 73 |
| EG001 | LID205255 Toric Ocular | Events reported in this group occurred while exposed to the lehfilcon A toric contact lenses | 0 | 142 | 0 | 142 | 0 | 142 |
| EG002 | LID205255 Toric Nonocular | Events reported in this group occurred while exposed to the lehfilcon A toric contact lenses | 0 | 71 | 0 | 71 | 0 | 71 |
| EG003 | Biofinity Toric Ocular | Events reported in this group occurred while exposed to the comfilcon A toric contact lenses | 0 | 146 | 0 | 146 | 0 | 146 |
| EG004 | Biofinity Toric Nonocular | Events reported in this group occurred while exposed to the comfilcon A toric contact lenses | 0 | 73 | 0 | 73 | 0 | 73 |
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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 | |
|---|---|---|---|---|
| Clinical Project Lead, CRD Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2022 | Jun 2, 2023 | 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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| Black or African American |
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| Asian |
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| Missing |
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| Day 30 |
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