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The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.
Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID018869, then AOHP | Other | Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection. |
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| AOHP, then LID018869 | Other | Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 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 contact lenses | Device | Commercially available, silicone hydrogel, spherical contact lenses used as indicated |
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| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30 | Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. | Day 30, each study lens type |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, CDMA Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Elsa Pao, OD | Oakland | California | 94607 | United States | ||
| Pacific Rims Optometry |
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Of the 166 enrolled, 3 subjects were exited from the study prior to randomization as screen failures, and 1 randomized subject was discontinued prior to exposure to the study lenses. This reporting group includes all subjects exposed to the study lenses, as treated (162).
Subjects were recruited from 10 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | LID018869, Then AOHP | Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE was used for daily contact lens cleaning and disinfection. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1, 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 | Sep 1, 2021 | Feb 13, 2023 |
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| Senofilcon A contact lenses | Device | Commercially available, silicone hydrogel, spherical contact lenses used as indicated |
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| CLEAR CARE | Device | Hydrogen peroxide-based contact lens cleaning and disinfecting solution |
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| San Francisco |
| California |
| 94127 |
| United States |
| Sabal Eye Care | Longwood | Florida | 32779 | United States |
| Vision Health Institute | Orlando | Florida | 32803 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| North Spartanburg Eye Center | Boiling Springs | South Carolina | 29316 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| Advancing Vision Research, LLC | Smyrna | Tennessee | 37167 | United States |
| Dr Christina R Chang & Associates, OD, PA | Plano | Texas | 75093 | United States |
| Dawn M. Rakich, OD | San Antonio | Texas | 78213 | United States |
| AOHP, Then LID018869 |
Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE was used for daily contact lens cleaning and disinfection. |
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| NOT COMPLETED |
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| Period 2, 30 Days |
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Safety Analysis Set: All subjects exposed to any study lenses.
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| ID | Title | Description |
|---|---|---|
| BG000 | LID018869, Then AOHP | Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE was used for daily contact lens cleaning and disinfection. |
| BG001 | AOHP, Then LID018869 | Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes during waking hours only for at least 10 hours per day for 30 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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| 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 | Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30 | Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. | Full Analysis Set: All randomized subjects who were exposed to any study lenses evaluated in this clinical study with data at Day 30. | Posted | Least Squares Mean | Standard Error | logMAR | Day 30, each study lens type | eyes | eyes |
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Adverse events (AEs) were collected from time of consent to study exit, approximately 65 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, as treated.
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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 | 162 | 0 | 162 | 0 | 162 |
| EG001 | LID018869 Ocular | Events reported in this group occurred while exposed to the lehfilcon A contact lenses. | 0 | 322 | 0 | 322 | 0 | 322 |
| EG002 | LID018869 Non-Ocular | Events reported in this group occurred while exposed to the senofilcon A contact lenses. | 0 | 161 | 0 | 161 | 0 | 161 |
| EG003 | AOHP Ocular | Events reported in this group occurred while exposed to the lehfilcon A contact lenses. | 0 | 320 | 0 | 320 | 0 | 320 |
| EG004 | AOHP Non-Ocular | Events reported in this group occurred while exposed to the senofilcon A contact lenses. | 0 | 160 | 0 | 160 | 0 | 160 |
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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 | |
|---|---|---|---|---|
| CDMA 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 28, 2021 | Feb 13, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| 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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| Multi-racial |
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Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.