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The purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.
Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 14 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 7 office visits. The total duration of study participation is approximately 40 days with approximately 28 days of lens wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID233309, then Oasys MF | Other | Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection. |
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| Oasys MF, then LID233309 | Other | Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serafilcon A multifocal contact lenses | Device | Investigational multifocal soft contact lenses |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Binocular Visual Acuity at Distance (4 Meters) at Week 1 | 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). No hypothesis testing was pre-specified for this endpoint. | Week 1 (Day 7 -0/+1 days) of each wear period. A wear period was 14 days (-0/+2 days) 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 |
|---|---|---|---|---|---|---|
| Kurata Eyecare Center | Los Angeles | California | 90013 | United States | ||
| Elsa Pao, OD |
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Of the 106 subjects enrolled, 2 subjects were discontinued prior to exposure to the study product. This reporting group population includes all subjects exposed to any study lenses evaluated in this study.
Subjects were enrolled at 8 investigative sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | LID233309, Then Oasys MF | Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses were worn in a daily wear mode both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period was 14 days (-0/+2). CLEAR CARE was used for daily cleaning and disinfection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Wear Period (Approx 14 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 | Jul 31, 2024 | Sep 22, 2025 |
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| Senofilcon A multifocal contact lenses | Device | Commercially available multifocal soft contact lenses |
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| CLEAR CARE® Cleaning & Disinfecting Solution | Device | Hydrogen peroxide-based contact lens cleaning and disinfection system |
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| Oakland |
| California |
| 94607 |
| United States |
| Drs. Giedd, P.A. | Maitland | Florida | 32751 | United States |
| Vision Health Institute | Orlando | Florida | 32803 | United States |
| Wesley Optometric Consulting | Medina | Minnesota | 55340 | 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 |
| FG001 | Oasys MF, Then LID233309 | Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses were worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period was 14 days (-0/+2). CLEAR CARE was used for daily cleaning and disinfection. |
| COMPLETED |
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| NOT COMPLETED |
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| Second Wear Period (Approx 14 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 | LID233309, Then Oasys MF | Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses were worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period was 14 days (-0/+2). CLEAR CARE was used for daily cleaning and disinfection. |
| BG001 | Oasys MF, Then LID233309 | Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses were worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period was 14 days (-0/+2). CLEAR CARE was used for daily 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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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Binocular Visual Acuity at Distance (4 Meters) at Week 1 | 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). No hypothesis testing was pre-specified for this endpoint. | Full Analysis Set with data at visit | Posted | Mean | Standard Deviation | logMAR | Week 1 (Day 7 -0/+1 days) of each wear period. A wear period was 14 days (-0/+2 days) according to randomization assignment. |
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Adverse Events (AEs) were collected from time of consent to study exit, approximately 40 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 | 104 | 0 | 104 | 0 | 104 |
| EG001 | LID233309 Ocular | Events reported in this group occurred while exposed to the serafilcon A multifocal contact lenses. | 0 | 0 | 0 | 200 | 0 | 200 |
| EG002 | LID233309 Nonocular | Events reported in this group occurred while exposed to the serafilcon A multifocal contact lenses. | 0 | 100 | 0 | 100 | 0 | 100 |
| EG003 | Oasys MF Ocular | Events reported in this group occurred while exposed to the senofilcon A multifocal contact lenses. | 0 | 0 | 0 | 198 | 0 | 198 |
| EG004 | Oasys MF Nonocular | Events reported in this group occurred while exposed to the senofilcon A multifocal contact lenses. | 0 | 99 | 0 | 99 | 0 | 99 |
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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 | Jun 25, 2024 | Sep 22, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| 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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| Multi-Racial |
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| Not Hispanic or Latino |
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