Visual Acuity
Conditions
Brief summary
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.
Interventions
DEVICEACUVUE OASYS 1-Day
Sphere CONTROL
DEVICEACUVUE OASYS MAX 1-Day
Sphere TEST
DEVICEACUVUE OASYS Multifocal
Multifocal CONTROL
DEVICEACUVUE OASYS MAX 1-Day Multifocal
Multifocal TEST
Toric CONTROL
DEVICEsenofilcon A based contact lens (toric) with new UV/HEV filter
Toric TEST
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study: The subject must: 1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Be between 18 and 70 (inclusive) years of age at the time of screening. 4. By self-report, habitually wear soft contact lenses (sphere, multifocal, toric) in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days. 5. If applicable, those subjects receiving the spherical lenses will need a vertex-corrected distance refraction within the range of -1.00 through -6.00 DS 6. If applicable, those subjects receiving the multifocal lenses will need a vertex-corrected distance refraction within the range of -1.00 through -6.00 DS 7. If applicable, those subjects receiving the toric lenses will need a vertex-corrected distance refraction within the range of -1.50 through -4.00 DS, -0.625 through -1.625 DC, and cylinder axes: 80/90/100, 170/180/10 8. The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye
Exclusion criteria
Potential subjects who meet any of the following criteria will be excluded from participating in the study: The subject must not: 1. Be currently pregnant or lactating. 2. Be currently using any ocular medications or have any ocular infection of any type. 3. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications. 4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. 5. Be currently wearing lenses in an extended wear modality. 6. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment. 7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. 8. (Phase 2 only): Have participated in Phase 1 of the study. 9. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that the investigator believes might contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). 10. Have a history of strabismus or amblyopia. 11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. 12. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Range at Phase 1 | Approximately 15 minutes post lens fitting | 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. |
| Visual Range at Phase 2 | Approximately 15 minutes post lens fitting | 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. |
| Motion Detection at Phase 1 | Approximately 15 minutes post lens fitting | 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. |
| Brightness Perception at Phase 1 | Approximately 15 minutes post lens fitting | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motion Detection at Phase 2 | Approximately 15 minutes post lens fitting | 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. |
| Brightness Perception at Phase 2 | Approximately 15 minutes post lens fitting | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Sphere Strata - Phase 1 Subjects who are spherical contact lens wearers | 11 |
| Multifocal Strata - Phase 1 Subjects who are multifocal contact lens wearers | 10 |
| Sphere Strata - Phase2 Subjects who are spherical contact lens wearers | 41 |
| Multifocal Strata - Phase 2 Subjects who are multifocal contact lens wearers | 40 |
| Toric Strata - Phase 2 Subjects who are toric contact lens wearers | 40 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Phase 2 Period 1 | Adverse Event | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Sphere Strata - Phase 1 | Total | Toric Strata - Phase 2 | Multifocal Strata - Phase 2 | Sphere Strata - Phase2 | Multifocal Strata - Phase 1 |
|---|---|---|---|---|---|---|
| Age, Continuous | 23.4 Years STANDARD_DEVIATION 3.04 | 36.5 Years STANDARD_DEVIATION 15.72 | 24.9 Years STANDARD_DEVIATION 5.28 | 51.0 Years STANDARD_DEVIATION 7.08 | 25.8 Years STANDARD_DEVIATION 6.49 | 50.9 Years STANDARD_DEVIATION 9.88 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 8 Participants | 2 Participants | 0 Participants | 6 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 14 Participants | 4 Participants | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 117 Participants | 33 Participants | 34 Participants | 32 Participants | 7 Participants |
| Region of Enrollment United States | 11 Participants | 142 Participants | 40 Participants | 40 Participants | 41 Participants | 10 Participants |
| Sex: Female, Male Female | 10 Participants | 114 Participants | 30 Participants | 37 Participants | 29 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 28 Participants | 10 Participants | 3 Participants | 12 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 10 | 0 / 40 | 0 / 41 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 10 | 0 / 40 | 0 / 41 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 10 | 0 / 40 | 0 / 41 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
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.
Time frame: Approximately 15 minutes post lens fitting
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A (Test) Sphere Strata - Phase 1 | Brightness Perception at Phase 1 | 1.109 log relative energy | Standard Deviation 0.0909 |
| Senofilcon A (Control) Sphere Strata - Phase 1 | Brightness Perception at Phase 1 | 1.081 log relative energy | Standard Deviation 0.1494 |
| Senofilcon A (Test) Multifocal Strata - Phase 1 | Brightness Perception at Phase 1 | 1.101 log relative energy | Standard Deviation 0.1388 |
| Senofilcon A (Control) Multifocal Strata - Phase 1 | Brightness Perception at Phase 1 | 1.041 log relative energy | Standard Deviation 0.2222 |
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.
Time frame: Approximately 15 minutes post lens fitting
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A (Test) Sphere Strata - Phase 1 | Motion Detection at Phase 1 | 1.725 mm | Standard Deviation 1.3575 |
| Senofilcon A (Control) Sphere Strata - Phase 1 | Motion Detection at Phase 1 | 2.881 mm | Standard Deviation 1.9824 |
| Senofilcon A (Test) Multifocal Strata - Phase 1 | Motion Detection at Phase 1 | 3.229 mm | Standard Deviation 2.3248 |
| Senofilcon A (Control) Multifocal Strata - Phase 1 | Motion Detection at Phase 1 | 2.716 mm | Standard Deviation 3.1286 |
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.
Time frame: Approximately 15 minutes post lens fitting
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A (Test) Sphere Strata - Phase 1 | Visual Range at Phase 1 | 3.232 log relative energy level | Standard Deviation 0.1658 |
| Senofilcon A (Control) Sphere Strata - Phase 1 | Visual Range at Phase 1 | 3.049 log relative energy level | Standard Deviation 0.2101 |
| Senofilcon A (Test) Multifocal Strata - Phase 1 | Visual Range at Phase 1 | 3.287 log relative energy level | Standard Deviation 0.1824 |
| Senofilcon A (Control) Multifocal Strata - Phase 1 | Visual Range at Phase 1 | 3.167 log relative energy level | Standard Deviation 0.1072 |
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.
Time frame: Approximately 15 minutes post lens fitting
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A (Test) Sphere Strata - Phase 1 | Visual Range at Phase 2 | 3.377 log relative energy level | Standard Deviation 0.1489 |
| Senofilcon A (Control) Sphere Strata - Phase 1 | Visual Range at Phase 2 | 3.156 log relative energy level | Standard Deviation 0.1181 |
| Senofilcon A (Test) Multifocal Strata - Phase 1 | Visual Range at Phase 2 | 3.181 log relative energy level | Standard Deviation 0.1649 |
| Senofilcon A (Control) Multifocal Strata - Phase 1 | Visual Range at Phase 2 | 3.020 log relative energy level | Standard Deviation 0.1412 |
Comparison: It was calculated that 41 (for the Multifocal strata) and 6 (for the Sphere strata) participants in each vision group randomized in a 1:1 fashion between the two sequences would have at least a power of 90% (for the Multifocal strata) and a power of 94% (for the Sphere strata) to detect a statistical superiority with respect to visual range.p-value: <0.000195% CI: [0.19, 0.25]Mixed Model Analysis
Comparison: It was calculated that 41 (for the Multifocal strata) and 6 (for the Sphere strata) participants in each vision group randomized in a 1:1 fashion between the two sequences would have at least a power of 90% (for the Multifocal strata) and a power of 94% (for the Sphere strata) to detect a statistical superiority with respect to visual range.p-value: <0.000195% CI: [0.14, 0.18]Mixed Model Analysis
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.
Time frame: Approximately 15 minutes post lens fitting
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A (Test) Sphere Strata - Phase 1 | Brightness Perception at Phase 2 | 1.356 log relative energy | Standard Deviation 0.067 |
| Senofilcon A (Control) Sphere Strata - Phase 1 | Brightness Perception at Phase 2 | 1.222 log relative energy | Standard Deviation 0.0615 |
| Senofilcon A (Test) Multifocal Strata - Phase 1 | Brightness Perception at Phase 2 | 1.360 log relative energy | Standard Deviation 0.0832 |
| Senofilcon A (Control) Multifocal Strata - Phase 1 | Brightness Perception at Phase 2 | 1.219 log relative energy | Standard Deviation 0.0843 |
Comparison: It was calculated that 29 participants in each group randomized in a 1:1 fashion between the two sequences would have at least 91% power to detect a statistical superiority with respect to motion detection.p-value: <0.000198.33% CI: [0.112, 0.17]Mixed Model Analysis
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.
Time frame: Approximately 15 minutes post lens fitting
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A (Test) Sphere Strata - Phase 1 | Motion Detection at Phase 2 | 3.894 mm | Standard Deviation 2.68 |
| Senofilcon A (Control) Sphere Strata - Phase 1 | Motion Detection at Phase 2 | 4.288 mm | Standard Deviation 2.9575 |
| Senofilcon A (Test) Multifocal Strata - Phase 1 | Motion Detection at Phase 2 | 3.499 mm | Standard Deviation 2.4146 |
| Senofilcon A (Control) Multifocal Strata - Phase 1 | Motion Detection at Phase 2 | 3.3376 mm | Standard Deviation 2.375 |
Comparison: It was calculated that 16 participants in each group randomized in a 1:1 fashion between the two sequences would have at least 92% power to detect a statistical superiority with respect to motion detection.p-value: 0.046598.33% CI: [0.64, 1.09]Mixed Model Analysis