Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Eligible subjects that are habitual wearers of daily disposable contact lenses in both eyes will be randomly assigned to sequence, Test/Control. |
|
| Control/Test | Experimental | Eligible subjects that are habitual wearers of daily disposable contact lenses in both eyes will be randomly assigned to sequence, Control/Test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUVUE® OASYS 1-DAY | Device | senofilcon A contact lenses made with a novel manufacturing technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall CLUE Comfort | Overall comfort 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. | 1-Week Follow-up |
| Overall CLUE Vision | Overall 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. | 1-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Performance | Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under both high luminance/low contrast conditions and low luminance/high contrast conditions at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For high illumination, the room was required to be >400 lux with low contrast charts. For low illumination, the room was required to be <2.5 lux. 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | ||
| Maitland Vision Center |
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
Not provided
Not provided
Not provided
Not provided
A total of 136 subjects were enrolled in this study. Of those enrolled, 135 were dispensed at least one study lens while, 1 subject failed to meet all eligibility criteria. Of those subjects dispensed a study lens, 127 completed the study while, 8 subjects were discontinued from the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A (Test)/ Senofilcon A (Control) | subjects that wore the senofilcon A (Test) lens in period 1 and the senofilcon A (Control) in period 2. |
| FG001 | Senofilcon A (Control)/ Senofilcon A (Test) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
Not provided
Not provided
| 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 10, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ACUVUE® OASYS 1-DAY | Device | senofilcon A contact lenses made with the current manufacturing technology |
|
|
| 1-Week Follow-up |
| Average Daily Wear Time (in Hours) | Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-Week Follow up evaluation. | 1-Week Follow-up |
| Maitland |
| Florida |
| 32751 |
| United States |
| Tallahassee Eye Center | Tallahassee | Florida | 32308 | United States |
| VisionPoint Eye Center | Bloomington | Illinois | 61704 | United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| EyeCare Professionals of Powell | Powell | Ohio | 43065 | United States |
| Frazier Vision, Inc. | Tyler | Texas | 75703 | United States |
subjects that wore the senofilcon A (Control) lens in period 1 and the senofilcon A (Test) in period 2.
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 |
|
|
All subjects dispensed a study lens.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects dispensed a 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 |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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 | Overall CLUE Comfort | Overall comfort 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. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | unit on a scale | 1-Week Follow-up |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Visual Performance | Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under both high luminance/low contrast conditions and low luminance/high contrast conditions at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For high illumination, the room was required to be >400 lux with low contrast charts. For low illumination, the room was required to be <2.5 lux. 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. | Posted | Mean | Standard Deviation | logMAR | 1-Week Follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Daily Wear Time (in Hours) | Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-Week Follow up evaluation. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | hours | 1-Week Follow-up |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Overall CLUE Vision | Overall 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. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | unit on a scale | 1-Week Follow-up |
|
|
Throughout the duration of the study; approximately 1 month per subject.
Not provided
Not provided
| 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 (Test) | Subjects that wore the Test lens in either the first or second period of the study. | 0 | 135 | 0 | 135 | 0 | 135 |
| EG001 | Senofilcon A (Control) | Subjects that wore the Control lens in either the first or second period of the study. | 0 | 135 | 0 | 135 | 0 | 135 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meredith Bishop, OD, MS, FAAO | Johnson & Johnson Vision Care, Inc. | 1-800-843-2020 | mbishop4@its.jnj.com |
| Sep 23, 2021 |
| Prot_SAP_000.pdf |
Not provided
| White |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|