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The purpose of this study is to obtain on-eye performance data to inform contact lens product development.
Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID017569, then Biofinity | Other | Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection. |
|
| Biofinity, then LID017569 | Other | Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance VA (logMAR) With Study Lenses | Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters 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 formal hypothesis testing was planned. | Day 30 after a minimum of 6 hours of wear, each product |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| CDMA Project Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Maitland | Florida | 32751 | United States | ||
| Alcon Investigative Site |
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This reporting group includes all randomized subjects/eyes (36/72) as treated. Note: Two subjects received investigational product misallocations and were exposed to the incorrect study product in the sequence.
Subjects were enrolled at 3 investigative sites located in the US.
| ID | Title | Description |
|---|---|---|
| FG000 | LID017569, Then Biofinity | Lehfilcon A contact lenses worn in Period 1, with comfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Wear Period (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 | Sep 13, 2019 | Apr 16, 2021 |
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| Comfilcon A contact lenses | Device | Commercially available silicone hydrogel contact lenses |
|
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| Multi-purpose disinfection solution | Device | Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses |
|
|
| Bloomington |
| Illinois |
| 61704 |
| United States |
| Alcon Investigative Site | Memphis | Tennessee | 38111 | United States |
| Biofinity, Then LID017569 |
Comfilcon A contact lenses worn in Period 1, with lehfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection. |
| COMPLETED |
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| NOT COMPLETED |
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| Second Wear Period (30 Days) |
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This analysis population includes all subjects exposed to any study lenses evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | LID017569 and Biofinity contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. Each product was worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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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 | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Distance VA (logMAR) With Study Lenses | Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters 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 formal hypothesis testing was planned. | This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study. | Posted | Mean | Standard Deviation | logMAR | Day 30 after a minimum of 6 hours of wear, each product | 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 participants. The safety analysis set includes all subjects/eyes exposed to any study lenses evaluated in this study. For treatment-emergent safety analyses, subjects/eyes were categorized under the actual study lenses exposed in the corresponding lens sequence.
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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 | Pre-treatment | Events reported in this group occurred prior to exposure to the study contact lenses | 0 | 36 | 0 | 36 | 0 | 36 |
| EG001 | LID017569 Ocular | Events reported in this group occurred while exposed to lehfilcon A contact lenses | 0 | 72 | 0 | 72 | 0 | 72 |
| EG002 | LID017569 Nonocular/Systemic | Events reported in this group occurred while exposed to lehfilcon A contact lenses | 0 | 36 | 0 | 36 | 0 | 36 |
| EG003 | Biofinity Ocular | Events reported in this group occurred while exposed to comfilcon A contact lenses | 0 | 72 | 0 | 72 | 0 | 72 |
| EG004 | Biofinity Nonocular/Systemic | Events reported in this group occurred while exposed to comfilcon A contact lenses | 0 | 36 | 0 | 36 | 0 | 36 |
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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 | Sep 24, 2019 | Apr 16, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Unknown or Not Reported |
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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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