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This is a 5-visit, single-arm, open-label, dispensing study. Each subject will be bilaterally fit with the test article for approximately 4 weeks of reusable daily wear with lens replacement occurring 2-weeks after initial dispensing. After 4 weeks of study lens wear, subjects will return to their habitual spectacles for one week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A | Experimental | Subjects that are habitual spectacle wearers that have never worn contact lenses and have had an eye exam and an updated spectacle prescription in the last 6 months will be enrolled and fitted into the senofilcon A TEST Lens for a total period of 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device | TEST Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptable Lens Fitting | Acceptable fit is determined by the eye care practitioner (ECP/investigator) and includes the following criteria; (1) physiological responses (No Grade 3 or higher slit lamp findings), (2) mechanical lens fitting (no unacceptable lens fitting in either eye), (3) subjects' assessment of comfort, vision and handling. | 4-Week Follow-up |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Between 18 and 39 (inclusive) years of age at the time of screening.
They are a contact lens 'neophyte'. In this work 'neophyte' is taken to mean any subject who has never been dispensed contact lenses. A subject who had taken part in a non-dispensing clinical study or had been fitted with contact lenses in practice but never went on to actually wear the lenses, is also classified as a 'neophyte'.
Habitual spectacles must have resulted from an eye exam within the past six months.
The subject must have worn the updated spectacles for at least two weeks.
Be a current wearer of prescription spectacles that provide corrected monocular visual acuity of 20/25 or better in each eye.
The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.
The subject's refractive cylinder must be -1.00 D or less in each eye.
Have spherocylindrical best corrected distance Snellen visual acuity of 20/25 or better in each eye.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vue Optical Boutique | Jacksonville | Florida | 32205 | United States | ||
| Atlantic Eye Institute |
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A total of 129 subjects were enrolled in this study. Of those enrolled, 127 subjects were assigned and dispensed the Test lens while, 2 subjects failed to meet all eligibility criteria. Of those dispensed, 115 subjects completed the study while, 12 subjects were discontinued from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A | All subjects wore the senofilcon A lens for the first 4-Weeks of the study and then wore their Habitual spectacles for a period of 1-Week after the 4-Weeks of lens wear. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Dispensed Subjects | All subjects dispensed the senofilcon A lens during any point in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Acceptable Lens Fitting | Acceptable fit is determined by the eye care practitioner (ECP/investigator) and includes the following criteria; (1) physiological responses (No Grade 3 or higher slit lamp findings), (2) mechanical lens fitting (no unacceptable lens fitting in either eye), (3) subjects' assessment of comfort, vision and handling. | All subjects who were administered a Test lens and completed through the 4-week evaluation in which the eye care practitioner completed the lens fitting assessment. | Posted | Number | Proportion of subjects | 4-Week Follow-up |
|
Approximately 4 weeks 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 | Senofilcon A | All subjects that wore the senofilcon A lens in either eye during any point of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Buch OD F.A.A.O- Sr. Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | +1 904 443-1707 | JBUCH@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 | Yes | No | No | Study Protocol | Oct 11, 2018 | Feb 28, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 13, 2019 | Feb 28, 2020 | SAP_001.pdf |
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| Jacksonville Beach |
| Florida |
| 32250 |
| United States |
| Sabal Eye Care | Longwood | Florida | 32792 | United States |
| Baker Vision Care | Macclenny | Florida | 32063 | United States |
| Georgia Center for Sight | Greensboro | Georgia | 30642 | United States |
| Advanced Eyecare | Raytown | Missouri | 64133 | United States |
| ABQ Eye Care | Albuquerque | New Mexico | 87109 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| Eyecare Professionals of Powell | Powell | Ohio | 43065 | United States |
| Frazier Vision Inc. | Tyler | Texas | 75703 | United States |
| Failed Insertion & removal |
|
| Protocol Violation |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Count of Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 0 |
| 127 |
| 0 |
| 127 |
| 0 |
| 127 |
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