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This is a single-masked, crossover, randomized-controlled, dispensing clinical trial. A total of approximately 70 myopic eligible subjects will be targeted to complete the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Eligible subjects that are habitual soft contact lenses will be randomized into one of the two possible lens wear sequences: Test/Control or Control/Test |
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| Control/Test | Experimental | Eligible subjects that are habitual soft contact lenses will be randomized into one of the two possible lens wear sequences: Test/Control or Control/Test |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJVC Investigational Multifocal Contact Lens (senofilcon A c3) | Device | TEST |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective Vision Scores | Subjective Overall Quality of Vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient- xperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | 1-Week Follow-up |
| Visual Acuity (logMAR) | High contrast bright illumination binocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicates better vision. The average logMAR visual acuity for each lens was reported. Note: The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). Acceptable Luminance Range for Distance (4M): 10.5-10.7 EV (181-208 cd/m2). Acceptable Luminance Range for Near (40cm) and Intermediate Guillon-Poling :10.8- 11.1 EV (223-274 cd/m2). | 1-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.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be at least 40 years of age and not greater than 70 years of age at the time of consent.
Subjects must own a wearable pair of spectacles if required for their distance vision.
The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more duration).
The subject must either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or, if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
The subject's distance spherical equivalent refraction must be in the range of -1.25 D to -3.75 D in each eye.
The subject's refractive cylinder must be ≤0.75 D in each eye.
The subject's ADD power must be in the range of +0.75 D to +2.50 D.
The subject must have distance best corrected visual acuity of 20/20-3 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. James Weber & Associates, PA | Jacksonville | Florida | 32205 | United States | ||
| VRC-East |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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A total of 67 subjects were enrolled into this study. Of those enrolled, 65 were dispensed at least one study lens, while 2 subjects failed to meet all eligibility criteria. Of those dispensed a study lens, 17 subjects completed the study prior to the study being terminated, while 45 subjects were discontinued. This study was terminated due to the COVID-19 Pandemic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control | Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period |
| FG001 | Control/Test |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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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 | Mar 5, 2020 |
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| Dailies Total 1® Multifocal Contact Lens | Device | CONTROL |
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| Jacksonville |
| Florida |
| 32256 |
| United States |
| Maitland Vision Center | Maitland | Florida | 32751 | United States |
| Kannarr Eye Care | Pittsburg | Florida | 43023 | United States |
| Visual Eyes | Roswell | Georgia | 30076 | United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
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| NOT COMPLETED |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Dispensed Subjects | All subjects dispensed a study lens. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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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 | Subjective Vision Scores | Subjective Overall Quality of Vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient- xperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | All available data | Posted | Mean | Standard Deviation | Units on a Scale | 1-Week Follow-up |
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| Primary | Visual Acuity (logMAR) | High contrast bright illumination binocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicates better vision. The average logMAR visual acuity for each lens was reported. Note: The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). Acceptable Luminance Range for Distance (4M): 10.5-10.7 EV (181-208 cd/m2). Acceptable Luminance Range for Near (40cm) and Intermediate Guillon-Poling :10.8- 11.1 EV (223-274 cd/m2). | All avaiable data. | Posted | Mean | Standard Deviation | logMAR | 1-Week Follow-up |
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Throughout the entire duration of the study. Up to 2-Week Follow-up for subjects that completed study. Thirty-two subjects were monitored up to the 1-Week evaluation since the study was terminated early due to COVID-19.
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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 | All subjects that wore the Test lens during either the first or second period of the study. | 0 | 45 | 0 | 45 | 0 | 45 |
| EG001 | Control | All subjects that wore the Control lens during either the first or second period of the study. | 0 | 49 | 0 | 49 | 0 | 49 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Karkkainen - Sr.Principal Research Optometrist | Johnson & Johnson Vision Care | 1-800-843-2020 | TKarkkai@its.jnj.com |
| Dec 20, 2021 |
| Prot_SAP_000.pdf |
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