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The purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.
Subjects will attend 3 study visits with a planned individual duration of participation of up to 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID223188, then Ultra MFT | Other | Lehfilcon A multifocal toric contact lenses worn first, with samfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection. |
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| Ultra MFT, then LID223188 | Other | Samfilcon A multifocal toric contact lenses worn first, with lehfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lehfilcon A multifocal toric contact lenses | Device | Investigational silicone hydrogel contact lenses |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Distance Visual Acuity (VA) With Study Lenses | Visual Acuity (VA) was assessed binocularly (both eyes together) with study lenses in place at a distance of 4 meters using letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR), where 0.0 logMAR equates to 20/20 Snellen (normal distance eyesight). A lower number indicates better visual acuity. No hypothesis testing is pre-specified for this endpoint. | Day 2, each wear period. A wear period was approximately 2 days. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, CRD 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, 9 were exited prior to study lens assignment as screen failures. This reporting group includes all participants exposed to any study lenses evaluated in this study (9).
Participants were recruited from 1 investigative site located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | LID223188, Then Ultra MFT | Lehfilcon A multifocal toric contact lenses worn first, with samfilcon A multifocal toric contact lenses worn second. Each product was worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE was used for daily contact lens 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 | May 24, 2023 |
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Subjects will wear the products (test and comparator) in a predetermined order.
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| Samfilcon A multifocal toric contact lenses | Device | Commercially available silicone hydrogel contact lenses |
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| CLEAR CARE | Device | Hydrogen peroxide based contact lens cleaning and disinfecting solution |
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| Ultra MFT, Then LID223188 |
Samfilcon A multifocal toric contact lenses worn first, with lehfilcon A multifocal toric contact lenses worn second. Each product was worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE was used for daily contact lens cleaning and disinfection. |
| COMPLETED |
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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 | LID223188, Then Ultra MFT | Lehfilcon A multifocal toric contact lenses worn first, with samfilcon A multifocal toric contact lenses worn second. Each product was worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE was used for daily contact lens cleaning and disinfection. |
| BG001 | Ultra MFT, Then LID223188 | Samfilcon A multifocal toric contact lenses worn first, with lehfilcon A multifocal toric contact lenses worn second. Each product was worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE was used for daily contact lens 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 | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Distance Visual Acuity (VA) With Study Lenses | Visual Acuity (VA) was assessed binocularly (both eyes together) with study lenses in place at a distance of 4 meters using letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR), where 0.0 logMAR equates to 20/20 Snellen (normal distance eyesight). A lower number indicates better visual acuity. No hypothesis testing is 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, each wear period. A wear period was approximately 2 days. |
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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. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more 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 contact lenses. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG001 | LID223188 Ocular | Events reported in this group occurred while exposed to lehfilcon A multifocal toric contact lenses. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | LID223188 Nonocular | Events reported in this group occurred while exposed to lehfilcon A multifocal toric contact lenses. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | Ultra MFT Ocular | Events reported in this group occurred while exposed to samfilcon A multifocal toric contact lenses. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG004 | Ultra MFT Nonocular | Events reported in this group occurred while exposed to samfilcon A multifocal toric contact lenses. | 0 | 9 | 0 | 9 | 0 | 9 |
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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 | |
|---|---|---|---|---|
| Clinical Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Jul 3, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D011305 | Presbyopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| 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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| Not Hispanic or Latino |
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