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This is a single-masked, 2×3 crossover, randomized-controlled, dispensing clinical trial to evaluate overall quality of vision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST/CONTROL/CONTROL | Experimental | Eligible subjects will be randomized into the sequence TEST/CONTROL/CONTROL. |
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| CONTROL/TEST/TEST | Experimental | Eligible subjects will be randomized into the sequence CONTROL/TEST/TEST |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJVC Investigational Multifocal Contact Lenses | Device | TEST |
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| Measure | Description | Time Frame |
|---|---|---|
| Clarity of Vision in Dim or Low Lighting | Clarity of vision in dim or low lighting was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision in dim or low lighting conditions. This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary. | 1-Week Follow-up |
| Clarity of Vision When Reading in Dim Light | Clarity of vision when reading in dim light was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision when reading in dim light(e.g., menu or bill in a restaurant). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary. | 1-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Clarity of Distance Vision | Clarity of Distance vision was assessed at the 1-week follow-up during each study period using the individual item: Clarity of distance vision (i.e., looking at things that are more than 5 feet away, such as street signs). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B- Excellent and Very Good, Middle Box-Good and B2B- Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study
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.
Be at least 40 years of age and not greater than 70 years of age at the time of consent.
Own a wearable pair of spectacles if required for their distance vision.
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).
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" (Appendix D).
The subject's distance spherical equivalent refraction (vertex corrected if ≥-4.25 D) must be in the range of -1.25 D to -5.75 D or +0.75 D to +3.25 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:
The subject must not:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vue Optical Boutique | Jacksonville | Florida | 32205 | United States | ||
| Stam & Associates Eye Care |
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 143 subjects were enrolled in this study. Of those enrolled, all 143 subjects were dispensed at least one study lens. Of those dispensed, 138 subjects completed the study while 5 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A C3/Delefilcon A/Delefilcon A | Subjects in this sequence were randomized to receive the senofilcon A C3 lens during the first period and the delefilcon A lens during the second and third periods. |
| FG001 | Delefilcon A/Senofilcon A C3/Senofilcon A C3 |
| 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 15, 2022 |
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| Dailies Total 1® Multifocal Contact Lenses | Device | CONTROL |
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| 1-Week Follow-up |
| Clarity of Intermediate Vision | Clarity of Intermediate vision was assessed at the 1-week follow-up during each study period using the individual item: Clarity of intermediate vision (i.e., looking at things 2-3 feet away, such as your computer screen). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary. | 1-Week Follow-up |
| Clarity of Near Vision | Clarity of Near vision was assessed at the 1-week follow-up during each study period using the individual item: Clarity of intermediate vision (i.e., looking at things close up, such as reading a book). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary. | 1-Week Follow-up |
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Sabal Eye Care | Longwood | Florida | 32779 | United States |
| Maitland Vision Center | Maitland | Florida | 32751 | United States |
| VisualEyes | Roswell | Georgia | 30076 | United States |
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States |
| Spectrum Eyecare | Jamestown | New York | 14750 | United States |
| Eye Associates of New York | Manhattan | New York | 10022 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
| Botetourt Eyecare, LLC | Salem | Virginia | 30076 | United States |
Subjects in this sequence were randomized to receive the delefilcon A lens during the first period and the senofilcon A C3 lens during the second and third periods. |
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| Period 2 |
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| Period 3 |
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All subjects dispensed at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hyperopes | Subjects were classified as Hyperopic if the distance spherical equivalent refraction was in the range of +0.75 D to +3.25 D. |
| BG001 | Myopes | Subjects were classified as Myopic if the distance spherical equivalent refraction was in the range of -5.75 D to -1.25 D. |
| BG002 | Total | Total of all reporting groups |
| 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 | Number | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Clarity of Vision in Dim or Low Lighting | Clarity of vision in dim or low lighting was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision in dim or low lighting conditions. This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary. | All dispensed subjects regardless of deviation from protocol and completion status. | Posted | Number | Percent | 1-Week Follow-up | Observations | Observations |
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| Primary | Clarity of Vision When Reading in Dim Light | Clarity of vision when reading in dim light was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision when reading in dim light(e.g., menu or bill in a restaurant). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary. | All dispensed subjects regardless of deviation from protocol and completion status. | Posted | Number | Percent | 1-Week Follow-up | Observations | Observations |
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| Secondary | Clarity of Distance Vision | Clarity of Distance vision was assessed at the 1-week follow-up during each study period using the individual item: Clarity of distance vision (i.e., looking at things that are more than 5 feet away, such as street signs). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B- Excellent and Very Good, Middle Box-Good and B2B- Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary. | All dispensed subjects regardless of deviation from protocol and completion status. | Posted | Number | Percent | 1-Week Follow-up | Observations | Observations |
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| Secondary | Clarity of Intermediate Vision | Clarity of Intermediate vision was assessed at the 1-week follow-up during each study period using the individual item: Clarity of intermediate vision (i.e., looking at things 2-3 feet away, such as your computer screen). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary. | All dispensed subjects regardless of deviation from protocol and completion status. | Posted | Number | Percent | 1-Week Follow-up | Observations | Observations |
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| Secondary | Clarity of Near Vision | Clarity of Near vision was assessed at the 1-week follow-up during each study period using the individual item: Clarity of intermediate vision (i.e., looking at things close up, such as reading a book). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary. | All dispensed subjects regardless of deviation from protocol and completion status. | Posted | Number | Percent | 1-Week Follow-up | Observations | Observations |
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Throughout the duration of the study; Approximately 17-21 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) |
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| EG000 | Senofilcon A C3 | Subjects that wore the senofilcon A C3 lens during any of the three study periods. | 0 | 142 | 0 | 142 | 0 | 142 |
| EG001 | Delefilcon A | Subjects that wore the delefilcon A lens during any of the three study periods. | 0 | 142 | 0 | 142 | 0 | 142 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R. Karkkainen, OD, MS, FAAO | Johnson & Johnson Vision Care, Inc. | 1-800-843-2020 | TKarkkai@its.jnj.com |
| Apr 25, 2023 |
| Prot_SAP_000.pdf |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Fair or Poor |
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