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The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.
Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID#224381, then AOHG MF | Other | Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection. |
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| AOHG MF, then LID#224381 | Other | Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lehfilcon A multifocal contact lenses | Device | Investigational silicone hydrogel multifocal contact lenses |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 prespecified for this endpoint. | Day 2, each study lens type worn during the corresponding crossover period |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| 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 |
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Of the 18 enrolled, 1 participant was exited prior to study start as a screen failure. This reporting group includes all participants exposed to any study lenses evaluated in this study (17).
Participants were recruited from 1 investigative site located in 1 country (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | LID#224381, Then AOHG MF | Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type was worn bilaterally (in both eyes) for approximately 2 days in a daily wear modality. CLEAR CARE was used for nightly cleaning and disinfection. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Wear Period (Approx. 2 Days) |
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| 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 | Feb 22, 2023 |
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| Lotrafilcon B multifocal contact lenses | Device | Commercially available silicone hydrogel multifocal contact lenses |
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| Hydrogen peroxide-based cleaning and disinfection system | Device | Commercially available cleaning and disinfection system for silicone hydrogel contact lenses |
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| AOHG MF, Then LID#224381 |
Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type was worn bilaterally (in both eyes) for approximately 2 days in a daily wear modality. CLEAR CARE was used for nightly cleaning and disinfection. |
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| NOT COMPLETED |
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| Second Wear Period (Approx. 2 Days) |
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This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | LID#224381, Then AOHG MF | Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type was worn bilaterally (in both eyes) for approximately 2 days in a daily wear modality. CLEAR CARE was used for nightly cleaning and disinfection. |
| BG001 | AOHG MF, Then LID#224381 | Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type was worn bilaterally (in both eyes) for approximately 2 days in a daily wear modality. CLEAR CARE was used for nightly 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 | years |
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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/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 | |||||||||||||||||||||||
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| Primary | 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 prespecified 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, each study lens type worn during the corresponding crossover period |
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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.
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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 | 17 | 0 | 17 | 0 | 17 |
| EG001 | LID#224381 Ocular | Events reported in this group occurred while exposed to lehfilcon A multifocal contact lenses. | 0 | 34 | 0 | 34 | 0 | 34 |
| EG002 | LID#224381 Nonocular | Events reported in this group occurred while exposed to lehfilcon A multifocal contact lenses. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG003 | AOHG MF Ocular | Events reported in this group occurred while exposed to lotrafilcon B multifocal contact lenses. | 0 | 34 | 0 | 34 | 0 | 34 |
| EG004 | AOHG MF Nonocular | Events reported in this group occurred while exposed to lotrafilcon B multifocal contact lenses. | 0 | 17 | 0 | 17 | 0 | 17 |
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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 | |
|---|---|---|---|---|
| Sr. Clinical Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Mar 19, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| 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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| American Indian or Alaska Native |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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