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This is a single-masked, randomized-controlled, dispensing clinical trial. A total of approximately 60 eligible hyperopic subjects will be targeted to complete this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Hyperopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Test/Control. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses. |
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| Control/Test | Experimental | Hyperopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Control/Test. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A Multifocal | Device | TEST Lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Vision Scores | 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-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. | 2-Week Follow-up |
| Vision Scores Comparison Between Test and Control | 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-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. | 2-Week Follow-up |
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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 between 40 and 70 years of age (inclusive).
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.
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 8 hours per wear day, for 1 month of 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".
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 |
|---|---|---|---|---|---|---|
| Golden Optometric Group | Whittier | California | 90606 | United States | ||
| Dr. James E. Weber |
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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In total, 71 subjects were enrolled in this study of which, 70 subjects were dispensed at least 1 study lens, 1subject failed to meet all eligibility criteria. Of those dispensed a study lens, 61 subjects completed the study while, 9 were discontinued from the study.
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| ID | Title | Description |
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| FG000 | Test/Control | Subjects that were randomized to receive the Test lens in both eyes during the first period and the Control lens in both eyes 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 |
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| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2018 |
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| senofilcon A Sphere | Device | TEST Lens Sphere |
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| etafilcon A Multifocal | Device | CONTROL Lens |
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| etafilcon A Sphere | Device | CONTROL Lens Sphere |
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| Jacksonville |
| Florida |
| 32205 |
| United States |
| Maitland Vision Center | Maitland | Florida | 32751 | United States |
| Wayne Golden, OD | Sarasota | Florida | 34232 | United States |
| Western Reserve Vision Care | Beechwood | Ohio | 44122 | United States |
| Procare Vision Center | Granville | Ohio | 43023 | United States |
Subjects that were randomized to receive the Control lens in both eyes during the first period and the Test lens in both eyes during the second period.
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| NOT COMPLETED |
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| Period 2 |
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| ID | Title | Description |
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| BG000 | 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 | |||||||||||||||||
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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 | Count of 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 | Vision Scores | 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-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. | All subjects that completed the study without a major protocol deviation. | Posted | Mean | Standard Deviation | units on a scale | 2-Week Follow-up |
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| Primary | Vision Scores Comparison Between Test and Control | 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-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. | All subjects that completed the study without a major protocol deviation. | Posted | Mean | Standard Deviation | units on a scale | 2-Week Follow-up |
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Throughout the entire duration of the study. Approximately 4 weeks 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 | Test | Subjects that wore the Test lens during either period of the study. | 0 | 70 | 0 | 70 | 0 | 70 |
| EG001 | Control | Subjects that wore the Control lens during either period of the study. | 0 | 70 | 0 | 70 | 0 | 70 |
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If there is a significant sequence effect in the analysis model for vision scores, an analysis will be performed using data from period 1 of the study. All conclusions are based on period 1.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Karkkainen, OD, MS, FAAO- Sr. Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 904-443-3402 | TKarkkai@its.jnj.com |
| Apr 10, 2020 |
| Prot_SAP_000.pdf |
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| Other |
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| Period 2 |
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