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This is a 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial that will last approximately 2 - 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control/Control | Experimental | Eligible subjects that are habitual soft contact lens wearers will be randomized to lens wear sequence, (Test/Control/Control). |
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| Control/Test/Test | Experimental | Eligible subjects that are habitual soft contact lens wearers will be randomized to lens wear sequence, (Control/Test/Test). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational senofilcon A C3 Multifocal Lens | Device | TEST |
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| Measure | Description | Time Frame |
|---|---|---|
| Binocular Visual Acuity (logMAR) | Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meters), intermediate (64 cm) and near (40 cm) under high lumiance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be beetween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | 1-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Overall Vision Scores | Overall vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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. The average CLUE vision score for each lens type was reported. |
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Inclusion Criteria:
Potential subjects must satisfy all 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" (Appendix E).
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 |
|---|---|---|---|---|---|---|
| Empire Eye and Laser Center | Bakersfield | California | 93309 | United States | ||
| James R. Dugue, OD |
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 81 subject were enrolled into this study. Of those enrolled, 78 were dispensed at least one study lens while 3 subjects failed to meet all eligibility criteria. Of those dispensed, 70 completed the study while 8 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control/Control | Subjects that wore the Test lens in a bilateral fashion during period 1 and the Control lens in an bilateral fashion during both the second and third study periods. |
| FG001 | Control/Test/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 | Oct 2, 2020 |
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| delefilcon A Multifocal Lens | Device | Dailies Total 1® Multifocal Contact Lens |
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| 1- Week Follow-up |
| Mission Viejo |
| California |
| 92691 |
| United States |
| Stame & Associates, Eye Care | Jacksonville | Florida | 32256 | United States |
| VRC-East | Jacksonville | Florida | 32256 | United States |
| St. Johns Eye Associates, PA | Saint Augustine | Florida | 32092 | United States |
| Spectrum Eyecare | Jamestown | New York | 14701 | United States |
| Eye Associates of New York | Manhattan | New York | 10022 | United States |
Subjects that wore the Control lens in a bilateral fashion during period 1 and the Test lens in an bilateral fashion during both the second and third study periods
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Dispensed Subjects | All subjects dispensed at least one 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 | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Number | 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 | Binocular Visual Acuity (logMAR) | Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meters), intermediate (64 cm) and near (40 cm) under high lumiance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be beetween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | Subjects that completed all study visits without a major protocol deviation impacting a primary or secondary endpoint. | Posted | Mean | Standard Deviation | logMAR | 1-Week Follow-up |
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| Secondary | Subjective Overall Vision Scores | Overall vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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. The average CLUE vision score for each lens type was reported. | Subjects that completed all study visits without a major protocol deviation impacting a primary or secondary endpoint. | Posted | Mean | Standard Deviation | units on a scale | 1- Week Follow-up |
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Throughout the entire duration of the study. Approximately 1 month 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 | Subjects that wore the Test lens during any of the three study periods. | 0 | 75 | 0 | 75 | 0 | 75 |
| EG001 | Control | Subjects that wore the Control lens during any of the three study periods. | 0 | 77 | 0 | 77 | 0 | 77 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R. Karkkainen, OD, MS, FAAO, Sr. Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 1-800-843-2020 | TKarkkai@its.jnj.com |
| Dec 21, 2021 |
| Prot_SAP_000.pdf |
| Lost to Follow-up |
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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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| Other |
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| Near |
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The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold +0.00 logMAR.
| It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence | Linear Mixed Model | Kenward and Roger Method was used for denominator degrees of freedom | Least-square mean | -0.059 | Standard Error of the Mean | 0.0100 | 2-Sided | 95 | -0.079 | -0.039 | Intermediate (64cm) | Superiority | The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold + 0.17 logMAR. |
| It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence | Linear Mixed Model | Kenward and Roger Method was used for the denominator degrees of freedom | Least-square Mean | 0.062 | Standard Error of the Mean | 0.0111 | 2-Sided | 95 | 0.040 | 0.084 | Near (40cm) | Superiority | The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold +0.17 logMAR. |
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