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This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Arm | Experimental | Eligible subjects who are habitual soft contact lens wearers will be fit with the TEST lens in both eyes, to wear the lens for a minimum of 6 hours a day, every day, between visits for approximately 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter | Device | Test Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| HLHC Binocular logMAR Visual Acuities | 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. Data from hyperopes and myopes were combined for this outcome since logMAR scores between the two populations are similar. | 2-Week Follow-up |
| CLUE Vision Scores | 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. | 2-Week Follow-up |
| Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees | Absolute rotation was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens. | 15-minutes after lens insertion |
| Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees |
| Measure | Description | Time Frame |
|---|---|---|
| CLUE Vision Scores | 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:
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 |
|---|---|---|---|---|---|---|
| Dr. James Weber & Associates, PA - City Square Blvd | Jacksonville | Florida | 32218 | 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 176 subjects were enrolled in this study. Of those enrolled, 171 subjects were dispensed the study lens, while 5 subjects failed to meet all eligibility criteria. Of those dispensed, 163 subjects completed the study while 8 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test (Senofilcon A C3) | Subject that wore the Test lens at any point 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 | Mar 25, 2024 |
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Rotational Stability was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was report for each lens.
| 15-minutes after lens insertion |
| 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. Data from the hyperope and myopes group were combined for this outcome since the rate of SFLs grade 3+ is similar for these two populations. | Up to 2-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 at the 1-week follow-up. Lens fit was a binary variable where unacceptable lens fit=1 and acceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Data from the hyperope and myopes group were combined for this outcome since lens fitting characteristics are similar for these two populations. | Up to 2-Week Follow-up |
| 2-Week Follow-up |
| CLUE Comfort Scores | 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 scores for each sphere stratum (Hyperope and Myope) were reported. | 2-Week Follow-up |
| CLUE Handling Scores | 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 scores for each sphere stratum (Hyperope and Myope) were reported. | 2-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. Data for the hyperope and myope groups were combined for this endpoint since the number of subjects needed to optimize vision is independent of which group a subject belongs to. | Up to 1-Week Follow-up |
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Omega Vision Center | Longwood | Florida | 32779 | United States |
| Maitland Vision Center - North Orlando Ave | Maitland | Florida | 32751 | United States |
| Mid-State Eye | Clinton | Illinois | 61727 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Birmingham Vision Care | Bloomfield Hills | Michigan | 48301 | United States |
| Center for Ophthalmic and Vision Research/Eye Associates of New York | Manhattan | New York | 10022 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| Luxe Vision and Optical | Powell | Ohio | 43065 | United States |
| Dr. David W. Ferris & Associates | Warwick | Rhode Island | 02888 | United States |
| Optometry Group, LLC | Memphis | Tennessee | 38111 | United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
| New River Vision Care | Oak Hill | West Virginia | 25901 | 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 | Myopes | Subjects were classified as Myopic if the distance spherical equivalent refraction was in the range of -1.25 D to -3.75 D. |
| BG001 | Hyperopes | Subjects were classified as Hyperopic if the distance spherical equivalent refraction was in the range of +1.25 D to +4.25 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 (NIH/OMB) | Count of Participants | 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 | HLHC Binocular logMAR Visual Acuities | 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. Data from hyperopes and myopes were combined for this outcome since logMAR scores between the two populations are similar. | All dispensed subjects regardless of deviation from protocol with data collected at the 2-week follow-up. | Posted | Mean | Standard Deviation | logMAR | 2-Week Follow-up |
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| Primary | CLUE Vision Scores | 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 2-week follow-up. | Posted | Mean | Standard Deviation | Units on a Scale | 2-Week Follow-up |
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| Primary | Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees | Absolute rotation was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens. | All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol. | Posted | Number | Proportion of eyes | 15-minutes after lens insertion | Eyes | Eyes |
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| Primary | Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees | Rotational Stability was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was report for each lens. | All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol. | Posted | Number | Proportion of eyes | 15-minutes after lens insertion | 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. Data from the hyperope and myopes group were combined for this outcome since the rate of SFLs grade 3+ is similar for these two populations. | All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol. | Posted | Number | Proportion of eyes | Up to 2-Week Follow-up | Eyes | Eyes |
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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 at the 1-week follow-up. Lens fit was a binary variable where unacceptable lens fit=1 and acceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Data from the hyperope and myopes group were combined for this outcome since lens fitting characteristics are similar for these two populations. | All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol. | Posted | Number | Proportion of eyes | Up to 2-Week Follow-up | Eyes | Eyes |
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| Secondary | CLUE Vision Scores | 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 2-week follow-up. | Posted | Mean | Standard Deviation | Units on a Scale | 2-Week Follow-up |
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| Secondary | CLUE Comfort Scores | 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 scores for each sphere stratum (Hyperope and Myope) were reported. | All dispensed subjects regardless of deviation from protocol with data collected at the 2-week follow-up. | Posted | Mean | Standard Deviation | Units on a Scale | 2-Week Follow-up |
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| Secondary | CLUE Handling Scores | 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 scores for each sphere stratum (Hyperope and Myope) were reported. | All dispensed subjects regardless of deviation from protocol with data collected at the 2-week follow-up. | Posted | Mean | Standard Deviation | Units on a Scale | 2-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. Data for the hyperope and myope groups were combined for this endpoint since the number of subjects needed to optimize vision is independent of which group a subject belongs to. | 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; approximately 3 weeks per subject.
All subjects dispensed the study lens.
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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) | Subject that wore the Test lens at any point during the study. | 0 | 171 | 0 | 171 | 0 | 171 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnson & Johnson Vision Care Study Contact | Johnson & Johnson Vision Care | 1-800-843-2020 | RFrankl1@its.jnj.com |
| Jun 20, 2025 |
| Prot_SAP_000.pdf |
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Superiority |
| It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively. | Mixed Model Analysis | The Satterthwaite Method was used for the calculation of the denominator degrees of freedom. | least-square mean estimate | -0.023 | Standard Error of the Mean | 0.0131 | 2-Sided | 95 | -0.050 | 0.005 | Visual Acuity scores at intermediate was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM). | Superiority |
| It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively. | Mixed Model Analysis | The Satterthwaite Method was used for the calculation of the denominator degrees of freedom. | least-square mean estimate | 0.083 | Standard Error of the Mean | 0.0152 | 2-Sided | 95 | 0.051 | 0.116 | Visual Acuity scores at near was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM). | Superiority |
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