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The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.
In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID022821, then AOHP | Other | Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. |
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| AOHP, then LID022821 | Other | Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serafilcon A contact lenses | Device | Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection |
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| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Distance VA With Study Lenses at Week 1 | Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. | Week 1 of each lens product worn during the corresponding crossover period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead Alcon Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurata Eyecare Center | Los Angeles | California | 90013 | United States | ||
| Dr. Elsa Pao, OD |
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Of the 190 enrolled, 3 participants were exited prior to randomization as screen failures. Of the 187 randomized, 1 participant was discontinued prior to exposure to the study lenses due to ocular pre-treatment adverse events. This reporting group includes all participants exposed to any study lenses (186).
Participants were recruited from 15 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | LID022821, Then AOHP | Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. |
| FG001 | AOHP, Then LID022821 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Wear Period, Approximately 7 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 | Apr 13, 2023 | May 17, 2024 |
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| Senofilcon A contact lenses | Device | Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection |
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| CLEAR CARE | Device | Hydrogen peroxide based contact lens cleaning and disinfecting solution |
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| Oakland |
| California |
| 94607 |
| United States |
| Pacific Rims Optometry | San Francisco | California | 94127 | United States |
| Omega Vision Center P.A. | Longwood | Florida | 32779 | United States |
| Kindred Optics at Maitland Vision | Maitland | Florida | 32751 | United States |
| Vision Health Institute | Orlando | Florida | 32803 | United States |
| Tallahassee Eye Center | Tallahassee | Florida | 32308 | United States |
| Heart of America Eye Care | Shawnee Mission | Kansas | 66204 | United States |
| The Eye Doctors Inc | Eden Prairie | Minnesota | 55344 | United States |
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States |
| SUNY College of Optometry Clinical Vision Research Center | New York | New York | 10036 | 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 |
| Total Eye Care PA | Memphis | Tennessee | 38119 | United States |
Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. |
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| NOT COMPLETED |
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| Second Wear Period, Approximately 7 Days |
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Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | LID022821, Then AOHP | Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. |
| BG001 | AOHP, Then LID022821 | Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for approximately 14 days. 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 | 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 VA With Study Lenses at Week 1 | Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. | Full Analysis Set: All randomized subjects who were exposed to any study lenses evaluated in this study with data at Week 1 visit. | Posted | Least Squares Mean | Standard Error | logMAR | Week 1 of each lens product worn during the corresponding crossover period | eyes | eyes |
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Adverse events (AEs) were collected from time of consent to study exit, approximately 28 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. 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 | 186 | 0 | 186 | 0 | 186 |
| EG001 | LID022821 - Ocular | Events reported in this group occurred while exposed to the serafilcon A contact lenses. | 0 | 364 | 0 | 364 | 0 | 364 |
| EG002 | LID022821 - Non-Ocular | Events reported in this group occurred while exposed to the serafilcon A contact lenses. | 0 | 182 | 0 | 182 | 0 | 182 |
| EG003 | AOHP - Ocular | Events reported in this group occurred while exposed to the senofilcon A contact lenses. | 0 | 370 | 0 | 370 | 0 | 370 |
| EG004 | AOHP - Non-Ocular | Events reported in this group occurred while exposed to the senofilcon A contact lenses. | 0 | 185 | 0 | 185 | 0 | 185 |
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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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2023 | May 17, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009216 | Myopia |
| 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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| Not Hispanic or Latino |
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Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.