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This is a 2-phase, single-site, non-dispensing, randomized, controlled, double-masked, 2x2 crossover study to objectively measure potential benefits of a new UV/HEV filter using psychophysical testing techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sphere TEST/CONTROL | Experimental | Eligible subjects who are habitual wearers of soft contact lenses that receive the sphere lenses will be randomized into the sphere TEST/CONTROL sequence. |
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| Sphere CONTROL/TEST | Experimental | Eligible subjects who are habitual wearers of soft contact lenses that receive the sphere lenses will be randomized into the sphere CONTROL/TEST sequence. |
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| Multifocal TEST/CONTROL | Experimental | Eligible subjects who are habitual wearers of soft contact lenses that receive the multifocal lenses will be randomized into the multifocal TEST/CONTROL sequence. |
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| Multifocal CONTROL/TEST | Experimental | Eligible subjects who are habitual wearers of soft contact lenses that receive the multifocal lenses will be randomized into the multifocal CONTROL/TEST sequence. |
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| Toric TEST/CONTROL | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUVUE OASYS 1-Day | Device | Sphere CONTROL |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Range at Phase 1 | Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target. Better visual range is indicated by a higher log-relative energy (LRE) of simulated haze (more haze) to obscure an otherwise highly visible target. | Approximately 15 minutes post lens fitting |
| Visual Range at Phase 2 | Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target. Better visual range is indicated by a higher log-relative energy (LRE) of simulated haze (more haze) to obscure an otherwise highly visible target. | Approximately 15 minutes post lens fitting |
| Motion Detection at Phase 1 | Motion detection is defined as the distance needed (in mm) to determine that a test light has moved from a standard position. Better motion detection is indicated by a smaller distance needed to detect that movement has occurred. | Approximately 15 minutes post lens fitting |
| Brightness Perception at Phase 1 | Brightness perception is defined as the log- relative energy needed to match a standard stimulus to a natural scene, across 10 different projected scenes. The perception of brighter image is indicated by a higher log-relative energy (LRE) needed to match the initially dim standard to the target. | Approximately 15 minutes post lens fitting |
| Measure | Description | Time Frame |
|---|---|---|
| Motion Detection at Phase 2 | Motion detection is defined as the distance needed (in mm) to determine that a test light has moved from a standard position. Better motion detection is indicated by a smaller distance needed to detect that movement has occurred. | Approximately 15 minutes post lens fitting |
| Brightness Perception at Phase 2 |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must:
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 |
|---|---|---|---|---|---|---|
| The University of Georgia | Athens | Georgia | 30602 | United States |
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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21 subjects (only sphere and multifocal subjects) were enrolled into Phase 1 of this study and 0 subjects failed to meet all eligibility criteria. All 21 subjects were dispensed at least 1 study lens and completed Phase 1.
124 subjects were enrolled into Phase 2. Of those enrolled into Phase 2, 121 subjects were dispensed at least 2 study lenses, while 3 subjects failed to meet all eligibility criteria. 120 subjects completed and 1 subject discontinued from the study during Phase 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A (Test) / Senofilcon A (Control) Sphere Strata | Subjects randomized to this sequence are spherical contact lens wearers that received the Test lens during the first period and then received the Control lens during the second period |
| FG001 | Senofilcon A (Control)/ Senofilcon A (Test) Sphere Strata |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1 Period 1 |
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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 | Jun 12, 2023 |
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Eligible subjects who are habitual wearers of soft contact lenses that receive the toric lenses will be randomized into the toric TEST/CONTROL sequence.
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| Toric CONTROL/TEST | Experimental | Eligible subjects who are habitual wearers of soft contact lenses that receive the toric lenses will be randomized into the toric CONTROL/TEST sequence. |
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| ACUVUE OASYS MAX 1-Day |
| Device |
Sphere TEST |
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| ACUVUE OASYS Multifocal | Device | Multifocal CONTROL |
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| ACUVUE OASYS MAX 1-Day Multifocal | Device | Multifocal TEST |
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| ACUVUE OASYS 1-Day for Astigmatism | Device | Toric CONTROL |
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| senofilcon A based contact lens (toric) with new UV/HEV filter | Device | Toric TEST |
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Brightness perception is defined as the log- relative energy needed to match a standard stimulus to a natural scene, across 10 different projected scenes. The perception of brighter image is indicated by a higher log-relative energy (LRE) needed to match the initially dim standard to the target. |
| Approximately 15 minutes post lens fitting |
Subjects randomized to this sequence are spherical contact lens wearers that received the Control lens during the first period and then received the Test lens during the second period |
| FG002 | Senofilcon A (Test) / Senofilcon A (Control) Multifocal Strata | Subjects randomized to this sequence are multifocal contact lens wearers that received the Test lens during the first period and then received the Control lens during the second period |
| FG003 | Senofilcon A (Control) / Senofilcon A (Test) Multifocal Strata | Subjects randomized to this sequence are multifocal contact lens wearers that received the Control lens during the first period and then received the Test lens during the second period |
| FG004 | Senofilcon A (Test) / Senofilcon A (Control) Toric Strata | Subjects randomized to this sequence are toric contact lens wearers that received the Test lens during the first period and then received the Control lens during the second period |
| FG005 | Senofilcon A (Control) / Senofilcon A (Control) Toric Strata | Subjects randomized to this sequence are toric contact lens wearers that received the Control lens during the first period and then received the Control lens during the second period |
| COMPLETED |
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| NOT COMPLETED |
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| Phase 1 Period 2 |
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| Phase 2 Period 1 |
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| Phase 2 Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sphere Strata - Phase 1 | Subjects who are spherical contact lens wearers |
| BG001 | Multifocal Strata - Phase 1 | Subjects who are multifocal contact lens wearers |
| BG002 | Sphere Strata - Phase2 | Subjects who are spherical contact lens wearers |
| BG003 | Multifocal Strata - Phase 2 | Subjects who are multifocal contact lens wearers |
| BG004 | Toric Strata - Phase 2 | Subjects who are toric contact lens wearers |
| BG005 | 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 | All subjects dispensed a study lens in Phase 1 | 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 | Visual Range at Phase 1 | Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target. Better visual range is indicated by a higher log-relative energy (LRE) of simulated haze (more haze) to obscure an otherwise highly visible target. | All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. | Posted | Mean | Standard Deviation | log relative energy level | Approximately 15 minutes post lens fitting |
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| Primary | Visual Range at Phase 2 | Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target. Better visual range is indicated by a higher log-relative energy (LRE) of simulated haze (more haze) to obscure an otherwise highly visible target. | All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. Based on the pre-specified primary analyses for Phase 2, the primary hypothesis testing was performed for Sphere and Multifocal strata only. | Posted | Mean | Standard Deviation | log relative energy level | Approximately 15 minutes post lens fitting |
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| Primary | Motion Detection at Phase 1 | Motion detection is defined as the distance needed (in mm) to determine that a test light has moved from a standard position. Better motion detection is indicated by a smaller distance needed to detect that movement has occurred. | All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. Subject were analyzed per planned randomized treatment. | Posted | Mean | Standard Deviation | mm | Approximately 15 minutes post lens fitting |
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| Primary | Brightness Perception at Phase 1 | Brightness perception is defined as the log- relative energy needed to match a standard stimulus to a natural scene, across 10 different projected scenes. The perception of brighter image is indicated by a higher log-relative energy (LRE) needed to match the initially dim standard to the target. | All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. Subject were analyzed per planned randomized treatment. | Posted | Mean | Standard Deviation | log relative energy | Approximately 15 minutes post lens fitting |
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| Secondary | Motion Detection at Phase 2 | Motion detection is defined as the distance needed (in mm) to determine that a test light has moved from a standard position. Better motion detection is indicated by a smaller distance needed to detect that movement has occurred. | All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. Subject were analyzed per planned randomized treatment. Based on the pre-specified primary analyses for Phase 2, the primary hypothesis testing was performed for Sphere and Multifocal strata only. | Posted | Mean | Standard Deviation | mm | Approximately 15 minutes post lens fitting |
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| Secondary | Brightness Perception at Phase 2 | Brightness perception is defined as the log- relative energy needed to match a standard stimulus to a natural scene, across 10 different projected scenes. The perception of brighter image is indicated by a higher log-relative energy (LRE) needed to match the initially dim standard to the target. | All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. Subject were analyzed per planned randomized treatment. Based on the pre-specified primary analyses for Phase 2, the primary hypothesis testing was performed for Sphere and Multifocal strata only. | Posted | Mean | Standard Deviation | log relative energy | Approximately 15 minutes post lens fitting |
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Time Frame: Throughout the duration of the study (Phase 1 and Phase 2); approximately 1 month per subject.
All subjects dispensed at least 1 study lens during either Phase 1 or Phase 2 of the study.
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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 | Senofilcon A (Test) Sphere Strata - Phase 1 | Spherical subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG001 | Senofilcon A (Control) Sphere Strata - Phase 1 | Spherical subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Senofilcon A (Test) Multifocal Strata - Phase 1 | Multifocal subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 1 of the study. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Senofilcon A (Control) Multifocal Strata - Phase 1 | Multifocal subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG004 | Senofilcon A (Test) Sphere Strata - Phase 2 | Spherical subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 2 of the study. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG005 | Senofilcon A (Control) Sphere Strata - Phase 2 | Spherical subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 2 of the study. | 0 | 41 | 0 | 41 | 0 | 41 |
| EG006 | Senofilcon A (Test) Multifocal Strata - Phase 2 | Multifocal subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 2 of the study. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG007 | Senofilcon A (Control) Multifocal Strata - Phase 2 | Multifocal subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 2 of the study. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG008 | Senofilcon A (Test) Toric Strata - Phase 2 | Toric subjects that wore the senofilcon A (Test) lens in either the first or second period in Phase 2 of the study. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG009 | Senofilcon A (Control) Toric Strata - Phase 2 | Toric subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 2 of the study. | 0 | 40 | 0 | 40 | 0 | 40 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Principal Research Optometrist | Johnson & Johnson Vision Care, Inc. (JJVC) | 904-608-7238 | jbuch@its.jnj.com |
| Oct 28, 2024 |
| Prot_SAP_000.pdf |
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| 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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| OG003 | Senofilcon A (Control) Multifocal Strata - Phase 2 | Multifocal subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 2 of the study |
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| Senofilcon A (Control) Multifocal Strata - Phase 1 |
Multifocal subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study |
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| OG003 | Senofilcon A (Control) Multifocal Strata - Phase 1 | Multifocal subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 1 of the study |
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| OG003 | Senofilcon A (Control) Multifocal Strata - Phase 2 | Multifocal subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 2 of the study |
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| OG003 | Senofilcon A (Control) Multifocal Strata - Phase 2 | Multifocal subjects that wore the senofilcon A (Control) lens in either the first or second period in Phase 2 of the study |
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