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This will be a single site, non-randomized, dispensing, brand-masked to the subject, bilateral single treatment study. There will be 2 study visits with a 10 to 14-day contact lens wear period between visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JJVC Marketed Contact Lens | Experimental | ACUVUE 2 Vivid Style |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJVC Marketed Contact Lens | Device | Female subjects that are habitual contact lens wearers between the ages of 18 to 39 will be dispensed 1 treatment of the JJVC Marketed Contact Lens during the 2-visit study. |
| Measure | Description | Time Frame |
|---|---|---|
| LogMAR Objective Vision (High Illumination/High Contrast) | Monocular high illuminance high contrast VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type. | 5 minutes after lens fitting |
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Inclusion Criteria:
-Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VRC East | Jacksonville | Florida | 32256 | United States |
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A total of 26 subjects were enrolled in the study. Of those enrolled, 24 subjects were assigned and administered. Of the total assigned subjects, 19 subjects completed the study, while 5 subjects were discontinued from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test | Subject that wore the etafilcon A lenses throughout the entire duration of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test | Subject that wore the etafilcon A lenses throughout the entire duration of the study. |
| 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 |
| 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 | LogMAR Objective Vision (High Illumination/High Contrast) | Monocular high illuminance high contrast VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type. | All subjects who received at least one study article regardless of the randomization status. | Posted | Mean | Standard Deviation | logMAR | 5 minutes after lens fitting | Eyes | Eyes |
|
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Throughout the entire duration of the study, approximately 10 to 14 days per subject.
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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 | Test | Subject that wore the etafilcon A lenses throughout the entire duration of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meredith Bishop OD, MS, FAAO | Johnson & Johnson Vision Care | 904-443-1396 | mbishop4@its.jnj.com |
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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 | Jan 8, 2018 | Feb 7, 2019 | Prot_SAP_000.pdf |
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Due to visible print differences, subjects and investigators will be aware of the patterns/variants of the investigational product. However, subjects will be masked to the lens brand to prevent bias during the lens discussions.
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| Year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Counts |
|---|
| Participants |
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| Eyes |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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