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The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).
Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits.
Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID018869, then AOHP (Part A) | Other | Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. |
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| AOHP, then LID018869 (Part A) | Other | Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. |
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| Biofinity (Part B) | Active Comparator | Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lehfilcon A contact lenses | Device | Investigational soft contact lenses for daily wear worn in Part A of the study |
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| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity (VA) (Part A) | Distance 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. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only. | Day 30, each study lens type |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, CDMA Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigator 6356 | Longwood | Florida | 32779 | United States | ||
| Alcon Investigator 6565 |
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Subjects were recruited from 4 investigative sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | LID018869, Then AOHP (Part A) | Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. |
| 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 | Feb 19, 2021 | Mar 31, 2022 |
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Part A is a crossover study. Part B is a single group study.
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Part A is double masked. Part B is single masked (trial subject).
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| Senofilcon A contact lenses | Device | Commercially available soft contact lenses for daily wear worn in Part A of the study |
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| Comfilcon A contact lenses | Device | Commercially available soft contact lenses for daily wear worn in Part B of the study |
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| Hydrogen peroxide-based cleaning and disinfecting solution | Device | For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study |
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| Maitland |
| Florida |
| 32751 |
| United States |
| Alcon Investigator 6401 | Warwick | Rhode Island | 02888 | United States |
| Alcon Investigator 6353 | Memphis | Tennessee | 38111 | United States |
| FG001 |
| AOHP, Then LID018869 (Part A) |
Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. |
| FG002 | Biofinity (Part B) | Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. |
| COMPLETED |
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| NOT COMPLETED |
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| Second Wear Period (30 Days) |
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Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | LID018869, Then AOHP (Part A) | Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. |
| BG001 | AOHP, Then LID018869 (Part A) | Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. |
| BG002 | Biofinity (Part B) | Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. |
| BG003 | 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, Customized | Count of Participants | Participants | No |
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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 (NIH/OMB) | Count of Participants | 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 | |||||||||||||||||||||||||
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| Primary | Distance Visual Acuity (VA) (Part A) | Distance 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. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only. | Safety Analysis Set | Posted | Mean | Standard Deviation | logMAR | Day 30, each study lens type | eyes | eyes |
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Adverse events (AE's) were collected from time of consent to study exit, approximately 8 weeks for subjects enrolled in Part A and approximately 4 weeks for subjects enrolled in Part B.
An AE was defined at any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of pretreatment and non-ocular AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
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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 Part A | Events reported in this group occurred prior to exposure to the study contact lenses. | 0 | 66 | 0 | 66 | 0 | 66 |
| EG001 | LID018869 Ocular (Part A) | 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 | AOHP Ocular | Events reported in this group occurred while exposed to senofilcon A contact lenses. | 0 | 130 | 0 | 130 | 0 | 130 |
| EG004 | AOHP Nonocular | Events reported in this group occurred while exposed to senofilcon A contact lenses. | 0 | 65 | 0 | 65 | 0 | 65 |
| EG005 | Pretreatment Part B | Events reported in this group occurred prior to exposure to the study contact lenses. | 0 | 66 | 0 | 66 | 0 | 66 |
| EG006 | Biofinity Ocular | Events reported in this group occurred while exposed to comfilcon A contact lenses. | 0 | 132 | 0 | 132 | 0 | 132 |
| EG007 | Biofinity Nonocular | Events reported in this group occurred while exposed to comfilcon A contact lenses. | 0 | 66 | 0 | 66 | 0 | 66 |
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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 | Mar 8, 2021 | Mar 31, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Equal to or greater than 65 years |
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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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| Asian |
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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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