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 clinical trial is to assess the clinical performance of LID223194 Multifocal (MF) contact lenses and commercially available Air Optix plus HydraGlyde (AOHG) MF contact lenses. Eligible subjects will wear each study lens type in a cross-over fashion as randomized for approximately 2 days.
Subjects will be expected to attend 3 scheduled visits for an individual duration of participation of up to 10 days.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID223194 MF, then AOHG MF | Other | Lehfilcon A multifocal contact lenses worn first, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection. |
|
| AOHG MF, then LID223194 MF | Other | Lotrafilcon B multifocal contact lenses worn first, followed by lehfilcon A multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lehfilcon A multifocal contact lenses | Device | Silicone hydrogel multifocal contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR) | VA was assessed binocularly (both eyes together) using a letter chart and measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No hypothesis testing was pre-specified for this endpoint. | Day 2 of each study lens type worn during the corresponding crossover period |
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 |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Creek Research Clinic | Johns Creek | Georgia | 30097 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
This reporting group includes all enrolled participants (16).
Participants were recruited from one investigative site located in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LID223194 MF, Then AOHG MF | Lehfilcon A multifocal contact lenses worn first, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn in both eyes for 2 days in a daily wear modality. CLEAR CARE was used for daily cleaning and disinfection. |
| FG001 | AOHG MF, Then LID223194 MF |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Wear Period (Approx 2 Days) |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Lotrafilcon B multifocal contact lenses | Device | Silicone hydrogel multifocal contact lenses |
|
|
| Hydrogen peroxide-based cleaning and disinfection system | Device | Commercially available cleaning and disinfection system for silicone hydrogel contact lenses |
|
|
Lotrafilcon B multifocal contact lenses worn first, followed by lehfilcon A multifocal contact lenses, as randomized. Each product was worn in both eyes for 2 days in a daily wear modality. CLEAR CARE was used for daily cleaning and disinfection. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Second Wear Period (Approx 2 Days) |
|
This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LID223194 MF, Then AOHG MF | Lehfilcon A multifocal contact lenses worn first, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn in both eyes for 2 days in a daily wear modality. CLEAR CARE was used for daily cleaning and disinfection. |
| BG001 | AOHG MF, Then LID223194 MF | Lotrafilcon B multifocal contact lenses worn first, followed by lehfilcon A multifocal contact lenses, as randomized. Each product was worn in both eyes for 2 days in a daily wear modality. CLEAR CARE was used for daily cleaning and disinfection. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| 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 Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR) | VA was assessed binocularly (both eyes together) using a letter chart and measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No hypothesis testing was pre-specified for this endpoint. | This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study. | Posted | Mean | Standard Deviation | logMAR | Day 2 of each study lens type worn during the corresponding crossover period |
|
|
|
Adverse events (AEs) were collected from time of consent to study exit, up to 10 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.
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. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG001 | LID223194 MF Ocular | Events reported in this group occurred while exposed to the lehfilcon A multifocal contact lenses. | 0 | 32 | 0 | 32 | 0 | 32 |
| EG002 | LID223194 MF Nonocular | Events reported in this group occurred while exposed to the lehfilcon A multifocal contact lenses. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | AOHG MF Ocular | Events reported in this group occurred while exposed to the lotrafilcon B multifocal contact lenses. | 0 | 32 | 0 | 32 | 0 | 32 |
| EG004 | AOHG MF Nonocular | Events reported in this group occurred while exposed to the lotrafilcon B multifocal contact lenses. | 0 | 16 | 0 | 16 | 0 | 16 |
Not provided
Not provided
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Feb 27, 2024 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| American Indian or Alaska Native |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|