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The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.
Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID210464, then AOHG MF | Other | Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting. |
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| AOHG MF, then LID210464 | Other | Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lehfilcon A multifocal contact lenses | Device | Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia |
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| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses | Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together 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. | Day 30, each wear period. A wear period was approximately 30 days. |
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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 |
|---|---|---|---|---|---|---|
| Kindred Optics at Maitland Vision | Maitland | Florida | 32751 | United States | ||
| Vision Health Institute |
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This reporting group includes all enrolled participants, as treated (101). Note, one subject that was randomized to AOHG MF, then LID210464 was exposed to LID210464, then AOHG MF instead.
Participants were recruited from 8 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | LID210464, Then AOHG MF | Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for daily contact lens cleaning and disinfecting. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1, Approximately 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 | May 31, 2022 | Aug 21, 2023 |
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| Lotrafilcon B multifocal contact lenses | Device | Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia |
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| CLEAR CARE® | Device | Hydrogen peroxide-based contact lens cleaning and disinfecting solution |
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| Orlando |
| Florida |
| 32803 |
| United States |
| Kannarr Eye Care LLC | Pittsburg | Kansas | 66762 | United States |
| The Eye Doctors, Inc. | Eden Prairie | Minnesota | 55344 | United States |
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States |
| ProCare Vision Centers, Inc. | Granville | Ohio | 43023 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| AOHG MF, Then LID210464 |
Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for nightly contact lens cleaning and disinfecting. |
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| NOT COMPLETED |
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| Period 2, Approximately 30 Days |
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Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study according to actual study lens exposure.
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| ID | Title | Description |
|---|---|---|
| BG000 | LID210464, Then AOHG MF | Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for daily contact lens cleaning and disinfecting. |
| BG001 | AOHG MF, Then LID210464 | Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for nightly contact lens cleaning and disinfecting. |
| 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 (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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses | Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together 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. | Full Analysis Set: All randomized subjects/eyes exposed to any study lenses evaluated in this study. | Posted | Least Squares Mean | Standard Error | logMAR | Day 30, each wear period. A wear period was approximately 30 days. | 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 AE's is reported in units of eyes according to actual study lens exposure. All other populations are reported in units of subjects.
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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 | 101 | 0 | 101 | 0 | 101 |
| EG001 | LID210464 Ocular | Events reported in this group occurred while exposed to the lehfilcon A contact lenses | 0 | 202 | 0 | 202 | 0 | 202 |
| EG002 | LID210464 Non-Ocular | Events reported in this group occurred while exposed to the lehfilcon A contact lenses | 0 | 101 | 0 | 101 | 0 | 101 |
| EG003 | AOHG MF Ocular | Events reported in this group occurred while exposed to the lotrafilcon B contact lenses | 0 | 200 | 0 | 200 | 0 | 200 |
| EG004 | AOHG MF Non-Ocular | Events reported in this group occurred while exposed to the lotrafilcon B contact lenses | 0 | 100 | 1 | 100 | 0 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood potassium decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
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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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 26, 2022 | Aug 21, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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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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Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.