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This is a single-masked, dispensing clinical trial. A total of approximately 48 myopic and 32 hyperopic eligible subjects will be targeted to complete the study. Subjects will be fit in the study lens, optimized if required and worn for approximately 2 weeks. Subjects will then have a washout period of approximately 1 week and be refit in the lenses and be dispensed for an additional 2 weeks of wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACUVUE® OASYS with Transitions™ | Experimental | Eligible subjects between the ages of 40 to 70 years of age and habitual wearers of soft contact lenses will be fitted with the study lens for two wearing cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUVUE® OASYS with Transitions™ | Device | JJVC Marketed Contact Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vision Scores | 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. | 2-Week Follow-up |
| Visual Performance (logMAR) | 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 lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be etween 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. | 2-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| CLUE Vision Comparison Between First Wearing Cycle and Second Wearing Cycle | Vision Scores wwere 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 between 40 and 70 years of age at the time of screening.
Subjects must own a wearable pair of spectacles if required for their distance vision.
The subject must be an adapted monovision 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's distance spherical equivalent refraction must be in the range of +3.50 D to -4.00 D in each eye.
The subject's refractive cylinder must be ≤1.00 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 best corrected distance 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 |
|---|---|---|---|---|---|---|
| VRC-East | Jacksonville | Florida | 32256 | United States | ||
| Advanced Eyecare |
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 91 subjects were enrolled in this study. Of those enrolled, 86 subjects were dispensed a least one study lens while 5 subjects failed to meet all eligibility criteria. Of those dispensed, 79 subjects completed the study, while 7 were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test | Subjects received the Test lens throughout the study. Subjects wore the Test lens twice for a period of approximately 2 weeks each. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Wearing Cycle |
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| Second Wearing Cycle |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test | Subjects received the Test lens throughout the study. Subjects wore the Test lens twice for a period of approximately 2 weeks each. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Vision Scores | 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 endpoint. | Posted | Mean | Standard Deviation | Units on a Scale | 2-Week Follow-up |
|
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 received the Test lens throughout the study. Subjects wore the Test lens twice for a period of approximately 2 weeks each. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Systematic Assessment | Not related to study treatment, subject was discontinued and AE was resolved by the end of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Karkkainen- Sr. Principal Research Optometrist | Johnson & Johnson Vision Care | 1-800-843-2020 | TKarkkai@its.jnj.com |
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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 3, 2019 | Mar 19, 2021 | Prot_SAP_000.pdf |
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| Up to 2-Week Follow-up |
| Raytown |
| Missouri |
| 64133 |
| United States |
| Manhattan Vision Associates | New York | New York | 10022 | United States |
| Western Reserve Vision Care, Inc. | Beachwood | Ohio | 44122 | United States |
| Dr. David W. Ferris & Associates | Warwick | Rhode Island | 02886 | United States |
| Lens Discomfort |
|
| Unsatisfactory Visual Response due to Test Article |
|
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Test (Second Wearing Cycle) | All subjects that wore the Test lens during the second wearing cycle |
|
|
|
| Primary | Visual Performance (logMAR) | 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 lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be etween 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 prtocol deviation impacting a primary endpoint | Posted | Mean | Standard Deviation | logMAR | 2-Week Follow-up |
|
|
|
|
| Secondary | CLUE Vision Comparison Between First Wearing Cycle and Second Wearing Cycle | Vision Scores wwere 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 endpoint. | Posted | Mean | Standard Deviation | Units on a Scale | Up to 2-Week Follow-up |
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| 0 |
| 86 |
| 1 |
| 86 |
| 0 |
| 86 |
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| Near (40 CM) |
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| Intermediate (64 CM) | Linear Mixed Model | The Kenward and Roger Method was used for the demoninator degrees of freedom | Least-square Mean | -0.028 | Standard Error of the Mean | 0.0191 | 2-Sided | 95 | -0.068 | 0.012 | Superiority | The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.17 logMAR. |
| Near (40 CM) | Linear Mixed Model | The Kenward and Roger Method was used for the demoninator degrees of freedom | Least-square Means | 0.037 | Standard Error of the Mean | 0.0191 | 2-Sided | 95 | -0.003 | 0.077 | Superiority | The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.17 logMAR |