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The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.
Subjects will be expected to attend 7 visits including a screening visit. The total duration of a subject's participation in the study will be approximately 40 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID226397, then AOfAHP | Other | Serafilcon A toric contact lenses worn in Period 1, with senofilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. |
|
| AOfAHP, then LID226397 | Other | Senofilcon A toric contact lenses worn in Period 1, with serafilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serafilcon A toric contact lenses | Device | Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion | The investigator will view the contact lens through a slit lamp (biomicroscope) and record the axis orientation (-179° to +180°) as the number of degrees away from the ideal location (90° axis) either positive or negative depending on the direction (nasal [+] or temporal [-]). No hypothesis testing was prespecified for this endpoint. | Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days according to randomization assignment. |
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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 |
|---|---|---|---|---|---|---|
| Dr. Elsa Pao, OD | Oakland | California | 94607 | United States | ||
| Pacific Rims Optometry |
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This reporting group includes all participants exposed to any study lenses evaluated in this study.
Participants were recruited from 7 investigative sites located in 1 country (US).
| ID | Title | Description |
|---|---|---|
| FG000 | LID226397, Then AOfAHP | Serafilcon A toric contact lenses worn in Period 1, with senofilcon A toric contact lenses worn in Period 2. Each product was worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE was used for nightly contact lens cleaning and disinfection. |
| FG001 |
| 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 | Sep 6, 2023 | Oct 15, 2024 |
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| Senofilcon A toric contact lenses | Device | Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) |
|
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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 |
| Drs. Giedd, P.A. | Maitland | Florida | 32751 | United States |
| Vision Health Institute | Orlando | Florida | 32803 | United States |
| Franklin Park Eye Center, PC | Franklin Park | Illinois | 60131 | United States |
| ProCare Vision Centers, Inc. | Granville | Ohio | 43023 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| AOfAHP, Then LID226397 |
Senofilcon A toric contact lenses worn in Period 1, with serafilcon A toric contact lenses worn in Period 2. Each product was worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE was used for nightly contact lens cleaning and disinfection. |
| COMPLETED |
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| NOT COMPLETED |
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| Second Wear Period (Approx. 14 Days) |
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Full Analysis Set: All randomized subjects/eyes exposed to any study lenses evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | LID226397, Then AOfAHP | Serafilcon A toric contact lenses worn in Period 1, with senofilcon A toric contact lenses worn in Period 2. Each product was worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE was used for nightly contact lens cleaning and disinfection. |
| BG001 | AOfAHP, Then LID226397 | Senofilcon A toric contact lenses worn in Period 1, with serafilcon A toric contact lenses worn in Period 2. Each product was worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE was used for nightly 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 | Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion | The investigator will view the contact lens through a slit lamp (biomicroscope) and record the axis orientation (-179° to +180°) as the number of degrees away from the ideal location (90° axis) either positive or negative depending on the direction (nasal [+] or temporal [-]). No hypothesis testing was prespecified for this endpoint. | Full Analysis Set: All randomized subjects/eyes exposed to any study lenses evaluated in this study. | Posted | Number | percentage of lenses | Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days according to randomization assignment. | eyes | eyes |
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Adverse Events (AEs) were collected from time of consent to study exit, up to 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/eyes exposed to any study lenses evaluated in this study.
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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 | LID226397 Ocular | Events reported in this group occurred while exposed to serafilcon A toric contact lenses. | 0 | 184 | 0 | 184 | 0 | 184 |
| EG001 | LID226397 Nonocular | Events reported in this group occurred while exposed to serafilcon A toric contact lenses. | 0 | 92 | 0 | 92 | 0 | 92 |
| EG002 | AOfAHP Ocular | Events reported in this group occurred while exposed to senofilcon A toric contact lenses. | 0 | 184 | 0 | 184 | 0 | 184 |
| EG003 | AOfAHP Nonocular | Events reported in this group occurred while exposed to senofilcon A toric contact lenses. | 0 | 92 | 0 | 92 | 0 | 92 |
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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. 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 | Sep 13, 2023 | Oct 15, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D006956 | Hyperopia |
| 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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| Multi-racial |
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| Not Hispanic or Latino |
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| Not Reported |
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