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This is a single-masked, 2×3 crossover, randomized controlled, dispensing clinical trial to evaluate the visual performance (logMAR) and subjective vision responses of the Test Lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control/Control | Experimental | Eligible subjects will be randomized to one of two possible lens wear sequences, Test/Control/Control. |
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| Control/Test/Test | Experimental | Eligible subjects will be randomized to one of two possible lens wear sequences, Control/Test/Test. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A C3 | Device | Test Lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) under high luminance high contrast (HLHC) lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 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 (64cm) 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 |
|---|---|---|
| Overall Vision | Overall vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience 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. |
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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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| 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 | ||
| St. Johns Eye Associates |
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 subjects were enrolled in this study. Of those enrolled, 78 were dispensed at least one study lens while, 3 subjects failed to meet all eligibility criteria. Of those enrolled, 68 completed the study while 10 subjects were discontinued from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A (C3) / Delefilcon A / Delefilcon A | Subjects that wore the senfilcon A lens during the first period and the delefilcon A lens during the second and third period. |
| 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 | Apr 23, 2021 |
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| Dailies Total 1® Multifocal Contact Lenses |
| Device |
Control Lens |
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| 1-Week Follow-up |
| Saint Augustine |
| Florida |
| 32092 |
| United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Procare Vision Centers | Granville | Ohio | 43023 | United States |
| Gulf Coast Vision Center | Houston | Texas | 77054 | United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
Subjects that wore the delefilcon A lens during the first period and the senofilcon A lens during the second and third period |
| 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 | 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 | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Visual Acuity | Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) under high luminance high contrast (HLHC) lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 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 (64cm) 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 | Overall Vision | Overall vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience 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. | 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 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 | Senofilcon A (C3) | Subjects that wore the senofilcon A lens during any of the three study periods. | 0 | 74 | 0 | 74 | 0 | 74 |
| EG001 | Delefilcon A | Subjects that wore the delefilcon A lens during any of the three study periods. | 0 | 75 | 0 | 75 | 0 | 75 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R. Karkkainen, OD, MS, FAAO | Johnson & Johnson Vision Care, Inc. | 1-904-254-0152 | TKarkkai@its.jnj.com |
| Jun 24, 2022 |
| Prot_SAP_000.pdf |
| Wrong add power dispensed |
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| White |
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| Near (40cm) |
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| Intermediate (64cm) | Mixed Model Analysis | Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom. | least-square mean difference | -0.030 | Standard Error of the Mean | 0.0108 | 2-Sided | 95 | -0.051 | -0.008 | Mean difference was calculated as senofilcon A - delefilcon A | Non-Inferiority | This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart. |
| Near (40cm) | Mixed Model Analysis | Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom. | least-square mean difference | -0.036 | Standard Error of the Mean | 0.0129 | 2-Sided | 95 | -0.062 | -0.011 | Mean difference was calculated as senofilcon A - delefilcon A | Non-Inferiority | This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart. |
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