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This is a single-masked, two-arm, parallel-group, randomized-controlled, dispensing clinical trial to evaluate the visual performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST Lens | Active Comparator | Eligible subjects who are habitual soft contact lens wearers will be randomized to the TEST Lens sequence for the duration of the study. |
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| CONTROL Lens | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomized to the CONTROL Lens sequence for the duration of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A C3 | Device | TEST Lens |
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| Dailies Total 1 Multifocal Contact Lenses |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular logMAR Visual Acuity | Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. 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 |
| CLUE Vision Score | Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patientreported 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. The average CLUE vision score for each lens type was reported. | 1-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance logMAR Visual Acuity | Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale at distance (4m) under high luminance high contrast condition assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. 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. |
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Inclusion Criteria:
Potential subjects must satisfy all 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".
The subject's distance spherical equivalent refraction must be in the range of -1.25 D to -3.75 D or +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 |
|---|---|---|---|---|---|---|
| Stam & Associates Eye Care | Jacksonville | Florida | 32256 | United States | ||
| Sabal 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 77 subjects were enrolled in this study. Of those enrolled, 74 subjects were dispensed at least one study lens, while 3 subject failed to meet all eligibility criteria. Of those dispensed, 69 subjects completed the study while 5 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test (Senofilcon A C3) | Subjects that wore the Test lens during the study. |
| FG001 | Control (Delefilcon A) | Subjects that wore the Control lens during the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Sep 29, 2021 |
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| Device |
CONTROL Lens |
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| 1-Week Follow-up |
| Longwood |
| Florida |
| 32779 |
| United States |
| Visual Eyes | Roswell | Georgia | 30076 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Birmingham Vision Care | Bloomfield Township | Michigan | 48301 | United States |
| Eye Associates of New York | New York | New York | 10022 | United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 028888 | United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
| COMPLETED |
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| NOT COMPLETED |
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All subjects dispensed a study lens with data collected at the 1-week follow-up evaluation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test (Senofilcon A C3) | Subjects that wore the Test lens during the study. |
| BG001 | Control (Delefilcon A) | Subjects that wore the Control lens during the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Binocular logMAR Visual Acuity | Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. 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. | All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol, with data at the 1-Week Follow-up Evaluation. | Posted | Mean | Standard Deviation | LogMAR | 1-Week Follow-up |
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| Primary | CLUE Vision Score | Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patientreported 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. The average CLUE vision score for each lens type was reported. | All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol, with data at the 1-Week Follow-up Evaluation. | Posted | Mean | Standard Deviation | Units on a scale | 1-Week Follow-up |
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| Secondary | Binocular Distance logMAR Visual Acuity | Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale at distance (4m) under high luminance high contrast condition assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. 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. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | LogMAR | 1-Week Follow-up |
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Throughout the duration of the study; The study duration for each subject was approximately 17±3 days.
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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 (Senofilcon A C3) | Subjects that wore the Control lens during the study. | 0 | 37 | 0 | 37 | 0 | 37 |
| EG001 | Control (Delefilcon A) | Subjects that wore the Test lens during the study. | 0 | 37 | 0 | 37 | 0 | 37 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R. Karkkainen, OD, MS, FAAO | Johnson & Johnson Vision Care, Inc. (JJVC) | (904)254-0152 | TKarkkai@its.jnj.com |
| Nov 16, 2022 |
| Prot_SAP_000.pdf |
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| Male |
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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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| Near (40cm) |
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| It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 12 subjects were required to test for superiority for intermediate. | Linear Mixed Model | Kenward and Roger method was used for denominator degrees of freedom. | Least-square Mean | 0.00 | Standard Error of the Mean | 0.022 | 2-Sided | 98.75 | -0.06 | 0.07 | Superiority | Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.17 logMAR for intermediate. |
| It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 60 subjects were required to test for superiority for near. | Linear Mixed Model | Kenward and Roger method was used for denominator degrees of freedom. | Least-square Mean | 0.09 | Standard Error of the Mean | 0.023 | 2-Sided | 98.75 | 0.02 | 0.16 | Superiority | Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.17 logMAR for near. |
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