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
Not provided
This study is a feasibility, multi-site, randomized, double-masked, 2-arm parallel group design, 2-week dispensing study with weekly visits to evaluate visual acuity.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST Lens | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomized into the TEST Lens for the duration of the study. |
|
| CONTROL Lens | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomized into the CONTROL Lens for the duration of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A contact lenses made with a novel manufacturing technology | Device | TEST Lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular logMAR Visual Acuity | Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance low contrast (HLLC), and low luminance high contrast (LLHC) at distance (4 meters) using an 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. | 2-Week Follow-up |
| Average Daily Wearing Time | Average daily wear time was assessed by calculating the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day. | 2-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| CLUE Comfort Score | Subjective 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. The average CLUE comfort score for each lens type was reported. |
Not provided
Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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 |
|---|---|---|---|---|---|---|
| VRC | Jacksonville | Florida | 32256 | United States | ||
| Flora Chen Poveda OD, PA - Orange Park |
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 123 subjects were enrolled in this study. Of those enrolled, all 123 subjects were dispensed at least one study lens. Of those dispensed, 118 subjects completed the study while 5 subjects were discontinued.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A Contact Lenses Made With the Current Manufacturing Technology | Subjects that wore the Senofilcon A contact lenses made with the current manufacturing technology lens during the study. |
| FG001 | Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Apr 19, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
| senofilcon A contact lenses made with the current manufacturing technology |
| Device |
CONTROL Lens |
|
| 2-Week Follow-up |
| CLUE Vision Score | Subjective 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. The average CLUE vision score for each lens type was reported. | 2-Week Follow-up |
| Orange Park |
| Florida |
| 32073 |
| United States |
| Tallahassee Eye Center | Tallahassee | Florida | 32308 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| William J. Bogus, O.D. | Salt Lake City | Utah | 84106 | United States |
| Botetourt Eyecare, LLC | Salem | Virginia | 24153 | United States |
Subjects that wore the Senofilcon A contact lenses made with a novel manufacturing technology lens during the study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All subjects dispensed a study lens
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Senofilcon A Contact Lenses Made With the Current Manufacturing Technology | Subjects that wore the Senofilcon A contact lenses made with the current manufacturing technology lens during the study. |
| BG001 | Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology | Subjects that wore the Senofilcon A contact lenses made with a novel manufacturing technology lens during the study. |
| BG002 | Total | Total of all reporting groups |
| 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 | Count of Participants | 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 | Monocular logMAR Visual Acuity | Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance low contrast (HLLC), and low luminance high contrast (LLHC) at distance (4 meters) using an 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 who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation. | Posted | Mean | Standard Deviation | logMAR | 2-Week Follow-up | eyes | eyes |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Average Daily Wearing Time | Average daily wear time was assessed by calculating the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day. | All subjects who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation. | Posted | Mean | Standard Deviation | hours | 2-Week Follow-up |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CLUE Comfort Score | Subjective 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. The average CLUE comfort score for each lens type was reported. | All subjects who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation. | Posted | Mean | Standard Deviation | Units on a scale | 2-Week Follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CLUE Vision Score | Subjective 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. The average CLUE vision score for each lens type was reported. | All subjects who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation. | Posted | Mean | Standard Deviation | Units on a scale | 2-Week Follow-up |
|
Throughout the duration of the study; The study duration for each subject was approximately 2 weeks.
All subjects dispensed a study lens.
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 Contact Lenses Made With the Current Manufacturing Technology | Subjects that wore the Senofilcon A contact lenses made with the current manufacturing technology lens during the study. | 0 | 62 | 0 | 62 | 0 | 62 |
| EG001 | Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology | Subjects that wore the Senofilcon A contact lenses made with a novel manufacturing technology lens during the study. | 0 | 61 | 0 | 61 | 0 | 61 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John R. Buch, OD, MS, FAAO | Johnson & Johnson Vision Care, Inc. (JJVC) | 800-843-2020 | jbuch@its.jnj.com |
| Jun 21, 2023 |
| Prot_SAP_000.pdf |
| Male |
|
| Black or African American |
|
| White |
|
| Multiple |
|
| Non-Inferiority |
| It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology for distance (4m) under LLHC. | Linear Mixed Model | Kenward and Roger method was used for denominator degrees of freedom. | Least square Mean (LSM) Difference | -0.010 | Standard Error of the Mean | 0.012 | 2-Sided | 95 | -0.030 | 0.020 | LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology | Non-Inferiority |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|