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The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.
Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 30 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 5 office visits. The total duration of study participation is approximately 66 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID230451, then ULTRA MFfA | Other | Lehfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by samfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period [30 days (-2/+1)]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE. |
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| ULTRA MFfA, then LID230451 | Other | Samfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by lehfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period [30 days (-2/+1)]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lehfilcon A multifocal for astigmatism contact lenses | Device | Investigational multifocal contact lenses for astigmatism |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses | Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen). | Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) according to randomization assignment. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr.Elsa Pao, O.D | Oakland | California | 94607 | United States | ||
| Pacific Rims Optometry |
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Of the 95 enrolled, 6 subjects were discontinued as screen failures prior to randomization, and 4 subjects were discontinued post randomization and prior to exposure to the study lenses. This reporting group includes all subjects exposed to any study lenses evaluated in this study.
Subjects were enrolled at 11 investigative sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | LID230451, Then ULTRA MFfA | Lehfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by samfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period [30 days (-2/+1)]. Study lenses were removed daily for cleaning and disinfection with CLEAR CARE. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Wear Period (Approx 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 | Aug 1, 2024 | Oct 31, 2025 |
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| Samfilcon A multifocal for astigmatism contact lenses | Device | Commercially available multifocal contact lenses for astigmatism |
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| CLEAR CARE® Cleaning & Disinfecting Solution | Device | Hydrogen peroxide-based contact lens cleaning and disinfection system |
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| Lehfilcon A multifocal for astigmatism contact lenses | Device | Investigational multifocal contact lenses for astigmatism |
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| CLEAR CARE® Cleaning & Disinfecting Solution | Device | Hydrogen peroxide-based contact lens cleaning and disinfection system |
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| San Francisco |
| California |
| 94127 |
| United States |
| Drs. Giedd, P.A. | Maitland | Florida | 32751 | United States |
| Vision Health Institute | Orlando | Florida | 32803 | United States |
| Kannarr Eye Care LLC | Pittsburg | Kansas | 66762 | United States |
| Wesley Optometric Consulting | Medina | Minnesota | 55340 | United States |
| Oculus Research, Inc. | Garner | North Carolina | 27529 | United States |
| ProCare Vision Centers, Inc. | Granville | Ohio | 43023 | United States |
| Insight Research Clinic LLC | Powell | Ohio | 43065 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| Dawn M. Rakich, OD | San Antonio | Texas | 78213 | United States |
| FG001 | ULTRA MFfA, Then LID230451 | Samfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by lehfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period [30 days (-2/+1)]. Study lenses were removed daily for cleaning and disinfection with CLEAR CARE. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout Period (Approx 2-4 Days) |
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| Second Wear Period (Approx 30 Days) |
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This analysis population includes all subjects exposed to any study lenses evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | LID230451, Then ULTRA MFfA | Lehfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by samfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period [30 days (-2/+1)]. Study lenses were removed daily for cleaning and disinfection with CLEAR CARE. |
| BG001 | ULTRA MFfA, Then LID230451 | Samfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by lehfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period [30 days (-2/+1)]. Study lenses were removed daily for cleaning and disinfection with CLEAR CARE. |
| 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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| Race/Ethnicity, Customized | 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 | Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses | Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen). | Full Analysis Set with data at visit | Posted | Mean | Standard Deviation | logMAR | Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) according to randomization assignment. |
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Adverse Events (AEs) were collected from time of consent to study exit, approximately 66 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 exposed to any study lenses evaluated in this study, as treated.
All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
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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 lenses. | 0 | 85 | 0 | 85 | 0 | 85 |
| EG001 | LID230451 Ocular | Events reported in this group occurred while exposed to the lehfilcon A multifocal for astigmatism contact lenses. | 0 | 0 | 0 | 166 | 0 | 166 |
| EG002 | LID230451 Nonocular | Events reported in this group occurred while exposed to the lehfilcon A multifocal for astigmatism contact lenses. | 0 | 83 | 0 | 83 | 0 | 83 |
| EG003 | ULTRA MFfA Ocular | Events reported in this group occurred while exposed to the samfilcon A multifocal for astigmatism contact lenses. | 0 | 0 | 0 | 168 | 0 | 168 |
| EG004 | ULTRA MFfA Nonocular | Events reported in this group occurred while exposed to the samfilcon A multifocal for astigmatism contact lenses. | 0 | 84 | 0 | 84 | 0 | 84 |
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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. Principal, Clinical Project Management, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 3, 2024 | Oct 31, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D001251 | Astigmatism |
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Male |
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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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Non-inferiority in distance VA was declared if upper confidence limit was less than 0.05.