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This will be a pilot, one-visit, open-label, non-dispensing study. Subjects will be given instructions and then attempt to insert and remove a contact lens in each eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A | Experimental | Subjects that are of at least 60 years of age and non-habitual contact lens wearers will receive instructions to insert and remove a contact lens from each eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device | ACUVUE OASYS® 1-DAY with HydraLuxe™ Technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Success Rate of Insertion and Removal of a Contact Lens | The subject attempted to insert a contact lens in each eye. The subject were allowed to voluntarily end the contact lens insertion activity at any time prior to the 20-minute time point. The time of insertion for each eye or the time of stopping the insertion process for each eye was recorded. Similarly, the time of removal for each lens or the time of stopping the removal process for each lens was recorded. | Lens insertion and Removal, up to 2-Hours |
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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.
Must be at least 60 years of age at the time of screening.
The subject must have normal eyes (i.e., no ocular medications or infections of any type).
The subject must have best corrected visual acuity (BCVA) of 20/30 or better in each eye.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Pall, OD, MS, FAAO | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VRC-East | Jacksonville | Florida | 32256 | United States |
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A total of 16 subjects were enrolled into this study. Of those enrolled, 2 failed to meet all eligibility criteria. Of 14 dispensed subjects all completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A | Subjects that wore senofilcon A during the entire duration of the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Dispensed Subjects | All subjects dispensed a study lens. |
| 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 | Overall Success Rate of Insertion and Removal of a Contact Lens | The subject attempted to insert a contact lens in each eye. The subject were allowed to voluntarily end the contact lens insertion activity at any time prior to the 20-minute time point. The time of insertion for each eye or the time of stopping the insertion process for each eye was recorded. Similarly, the time of removal for each lens or the time of stopping the removal process for each lens was recorded. | All subjects who successfully ompleted all study visits and did not substanially deviate from the protocol as deterined by the trial cohort review committee prior to database lock. | Posted | Number | Percentage of eyes | Lens insertion and Removal, up to 2-Hours | Eyes | Eyes |
|
Throughout the entire duration of the study. Approximately 1 day 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 | Subjects that wore the senofilcon A during any in this study. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall OD, MS, FAAO- Director of Clinical Sciences | Johnson & Johnson | 9044431290 | BPALL@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 | Jun 20, 2018 | Jul 1, 2019 | Prot_SAP_000.pdf |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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