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The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the visual performance of the study lenses.
The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the visual performance of the study lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Market Product | Experimental | Eligible subjects will be dispensed the study lenses in a bilateral fashion and will be in the treatment for approximately 5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bausch + Lomb Ultra® Multifocal for Astigmatism | Device | Study Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular High Luminance High Contrast 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. | 4-Week Follow-up |
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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 and not more than 70 years of age at the time of screening.
Own a wearable pair of spectacles if required for their distance vision.
Be an adapted soft contact lens wearer in both eyes (i.e. has worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for the past month).
Be an existing wearer of a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
Have distance spherical component of refraction in the range of either -1.25 D to -3.75 D or +1.25 to +3.75 D in each eye.
Have refractive cylinder in the range of -0.75 D to -1.75 D in each eye, with their cylinder axis 90°±25°.
Have near ADD power requirement in the range of +0.75 D to +2.50 D in each eye.
Have best corrected distance visual acuity of 20/20-3 or better in each eye.
Exclusion Criteria:
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 75 subjects were enrolled into this study. Of those enrolled, 72 were dispensed a study lens, while 3 subjects failed to meet all eligibility criteria. Of those dispensed, 62 subjects completed, and 10 subjects discontinued from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Samfilcon A | Subjects that were dispensed the study lens. |
| 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 | Oct 29, 2021 |
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Subjects will be unaware of the identity of the investigational product to help reduce potential bias
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| Jacksonville |
| Florida |
| 32256 |
| United States |
| VRC-East | Jacksonville | Florida | 32256 | United States |
| Maitland Vision Center | Maitland | Florida | 32751 | United States |
| The Eyecare Studio | Decatur | Georgia | 13850 | United States |
| Ctr For Opht and Vision Rsrch At Eye Associates Of New York | Manhattan | New York | 10222 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Vision Boutique | Houston | Texas | 77005 | United States |
| Botetourt Eyecare LLC | Salem | Virginia | 24153 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
All subjects dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Samfilcon A | Subjects that were dispensed the study lens. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 High Luminance High Contrast 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 completed subjects. | Posted | Mean | Standard Deviation | LogMAR | 4-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 | Samfilcon A | Subjects dispensed the study lens. | 0 | 72 | 0 | 72 | 0 | 72 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ross Franklin, BAppSc-Optom | Johnson & Johnson Vision Care (JJVC) | 1-800-843-2020 | RFRANKL1@its.jnj.com |
| Jan 5, 2023 |
| Prot_SAP_001.pdf |
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| Native Hawaiian or Other Pacific Islander |
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| White |
|
| Title | Measurements |
|---|---|
|
Intermediate (64cm) |
| Mixed Models Analysis |
Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom. |
| Least-square Mean |
| -0.01 |
| Standard Error of the Mean |
| 0.022 |
| 2-Sided |
| 95 |
| -0.06 |
| 0.04 |
The upper limit of each 95% confidence interval was compared to 0.17 logMAR for intermediate. |
| Superiority |
| Near (40cm) | Mixed Models Analysis | Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom. | Least-square Mean | 0.09 | Standard Error of the Mean | 0.024 | 2-Sided | 95 | 0.04 | 0.15 | The upper limit of each 95% confidence interval was compared to 0.17 logMAR for near. | Superiority |