Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the clinical performance of an investigational contact lens 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 60 days (30 days for each product).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID018869, 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 during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection. |
|
| Biofinity, then LID018869 | Other | Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lehfilcon A contact lenses | Device | Investigational silicone hydrogel contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Distance Visual Acuity (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). On Day 30, VA was assessed after 6-8 hours of wear. 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 1, Day 30 after 6-8 hours of wear, each product |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, CDMA 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
This reporting group includes all subjects/eyes (66/132) exposed to any study lenses evaluated in this study as treated (Safety Analysis Set)
Subjects were enrolled at 5 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | LID018869, Then Biofinity | Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection. |
| FG001 | Biofinity, Then LID018869 | Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Wear Period (30 Days ± 2 Days) |
|
| ||||||||||||||||||
| Second Wear Period (30 Days ± 2 Days) |
|
Safety Analysis Set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LID018869, Then Biofinity | Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection. |
| BG001 |
| 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 (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). On Day 30, VA was assessed after 6-8 hours of wear. 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. | Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study. | Posted | Mean | Standard Deviation | logMAR | Day 1, Day 30 after 6-8 hours of wear, each product | eyes | eyes |
|
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.
Not provided
| 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CDMA Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 9, 2020 | Sep 10, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2020 | Sep 10, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comfilcon A contact lenses | Device | Commercially available silicone hydrogel contact lenses |
|
|
| CLEAR CARE | Device | Hydrogen peroxide-based cleaning and disinfecting solution |
|
| Bloomington |
| Illinois |
| 61704 |
| United States |
| Alcon Investigative Site | Pittsburg | Kansas | 66762 | United States |
| Alcon Investigative Site | Shawnee Mission | Kansas | 66204 | United States |
| Alcon Investigative Site | Memphis | Tennessee | 38111 | United States |
| NOT COMPLETED |
|
| Biofinity, Then LID018869 |
Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection. |
| 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 (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Biofinity | Comfilcon A contact lenses worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection. |
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | LID018869 - Ocular | Events reported in this group occurred while exposed to lehfilcon A contact lenses | 0 | 132 | 0 | 132 | 0 | 132 |
| EG002 | LID018869 - Nonocular | Events reported in this group occurred while exposed to lehfilcon A contact lenses | 0 | 66 | 0 | 66 | 0 | 66 |
| EG003 | Biofinity - Ocular | Events reported in this group occurred while exposed to comfilcon A contact lenses | 0 | 130 | 0 | 130 | 0 | 130 |
| EG004 | Biofinity - Nonocular | Events reported in this group occurred while exposed to comfilcon A contact lenses | 0 | 65 | 0 | 65 | 0 | 65 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.