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This is a single-masked, single-arm, dispensing clinical trial that will evaluate vision, eye health and fit acceptance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST Lens | Experimental | Eligible subjects who are habitual soft contact lens wearers will be given the TEST Lens for the duration of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJVC Investigational Multifocal Contact Lenses manufactured in senofilcon A C3 | Device | TEST Lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Binocular 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. | 1-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 sphere stratum (Hyperope and Myope) was reported. | 1-Week Follow-up |
| Proportion of Eyes With Unacceptable Lens Fitting | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion, the 1-week follow-up and any unscheduled visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. | Up to 1-Week Follow-up |
| Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 sphere stratum (Hyperope and Myope) was reported. |
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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:
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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 140 subjects were enrolled in this study. Of those enrolled, 139 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, 136 subjects completed the study while 3 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test (Senofilcon A C3) | Subjects randomized to receive the Test lens during the study |
| 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 | Jan 5, 2022 |
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| Up to 1-Week Follow-up |
| 1-Week Follow-up |
| CLUE Comfort Score | Subjective 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. The average CLUE comfort score was reported. The pre-specified aim was not to compare comfort between the hyperope and myope subgroups, therefore, comfort scores were reported for both groups combined. | 1-Week Follow-up |
| CLUE Handling Score | Subjective Handling 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 handling score was reported. The pre-specified aim was not to compare comfort between the hyperope and myope subgroups, therefore, comfort scores were reported for both groups combined. | 1-Week Follow-up |
| Proportion of Subject Achieving Optimal Lens Pair in 4 Lenses or Less | The number of lenses to achieve the optimal pair for each subject was calculated as the original pair (2) plus all the required modifications to reach the optimal pair. In this study the minimum number of lenses per subject used was 2 where the maximum possible number of lenses used was 10. The data was dichotomized as Y=1 if the subject was able to achieve optimal lens pair in 4 lenses or lenses or less and 0 otherwise. A lens modification was performed if the subject reports unsatisfactory vision or was unable to obtain 20/30 distance visual acuity in both eyes. If the subject reported satisfactory vision with the lenses a modification was not required. However, based upon the investigator's findings on the measured visual acuity and/or over- refraction a modification may have been performed. | Up to 1-Week Follow-up |
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Maitland Vision Center - North Orlando Ave | Maitland | Florida | 32751 | United States |
| Tallahassee Eye Center | Tallahassee | Florida | 32308 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Birmingham Vision Care | Bloomfield Hills | Michigan | 48601 | United States |
| Eye Associates of New York | Manhattan | New York | 10022 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Dr. David W. Ferris & Associates | Warwick | Rhode Island | 02888 | United States |
| Optometry Group, LLC | Memphis | Tennessee | 38111 | United States |
| Vision Optique | Houston | Texas | 77005 | United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
| COMPLETED |
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| NOT COMPLETED |
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All subjects dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hyperopes | Subjects were classified as Hyperopic if the distance spherical equivalent refraction was in the range of +0.75 D to +3.25 D. |
| BG001 | Myopes | Subjects were classified as Myopic if the distance spherical equivalent refraction was in the range of -5.75 D to -1.25 D. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Binocular 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 dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up. | Posted | Mean | Standard Deviation | LogMAR | 1-Week Follow-up |
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| Primary | 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 sphere stratum (Hyperope and Myope) was reported. | All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up. | Posted | Mean | Standard Deviation | Units on a scale | 1-Week Follow-up |
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| Primary | Proportion of Eyes With Unacceptable Lens Fitting | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion, the 1-week follow-up and any unscheduled visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. | All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol. | Posted | Number | Proportion of eyes | Up to 1-Week Follow-up | Eyes | Eyes |
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| Primary | Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported. | All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol. | Posted | Number | Porportion of eyes | Up to 1-Week Follow-up | Eyes | Eyes |
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| 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 sphere stratum (Hyperope and Myope) was reported. | All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up. | Posted | Mean | Standard Deviation | Units on a scale | 1-Week Follow-up |
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| Secondary | CLUE Comfort Score | Subjective 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. The average CLUE comfort score was reported. The pre-specified aim was not to compare comfort between the hyperope and myope subgroups, therefore, comfort scores were reported for both groups combined. | All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up. | Posted | Mean | Standard Deviation | Units on a scale | 1-Week Follow-up |
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| Secondary | CLUE Handling Score | Subjective Handling 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 handling score was reported. The pre-specified aim was not to compare comfort between the hyperope and myope subgroups, therefore, comfort scores were reported for both groups combined. | All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up. | Posted | Mean | Standard Deviation | Units on a scale | 1-Week Follow-up |
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| Secondary | Proportion of Subject Achieving Optimal Lens Pair in 4 Lenses or Less | The number of lenses to achieve the optimal pair for each subject was calculated as the original pair (2) plus all the required modifications to reach the optimal pair. In this study the minimum number of lenses per subject used was 2 where the maximum possible number of lenses used was 10. The data was dichotomized as Y=1 if the subject was able to achieve optimal lens pair in 4 lenses or lenses or less and 0 otherwise. A lens modification was performed if the subject reports unsatisfactory vision or was unable to obtain 20/30 distance visual acuity in both eyes. If the subject reported satisfactory vision with the lenses a modification was not required. However, based upon the investigator's findings on the measured visual acuity and/or over- refraction a modification may have been performed. | All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol. | Posted | Number | Proportion of subjects | Up to 1-Week Follow-up |
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Throughout the duration of the study; The study duration for each subject was approximately 7±3 days.
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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 (Senofilcon A C3) | Subjects that wore the Test (senofilcon A C3) lens during the study. | 0 | 139 | 0 | 139 | 0 | 139 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R. Karkkainen | Johnson & Johnson Vision Care, Inc. (JJVC) | (904)254-0152 | TKarkkai@its.jnj.com |
| Jan 27, 2023 |
| Prot_SAP_000.pdf |
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| Male |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Title | Measurements |
|---|---|
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It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 11 subjects were required to test the primary hypothesis for Intermediate. |
| Mean Population Estimate |
| -0.04 |
| Standard Error of the Mean |
| 0.007 |
| 2-Sided |
| 99 |
| -0.06 |
| -0.02 |
| Superiority |
A superiority Margin of 0.17 logMAR was used for Intermediate. |
| It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 48 subjects were required to test the primary hypothesis for Near. | Mean Population Estimate | 0.07 | Standard Error of the Mean | 0.009 | 2-Sided | 99 | 0.05 | 0.09 | Superiority | A superiority Margin of 0.17 logMAR was used for near. |
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