Visual Performance
Conditions
Brief summary
This is a bilateral, non-dispensing, randomized, subject masked, four visits, 3-period by 3- treatment crossover study. The objective of this study is to evaluate the effect of JJVC senofilcon A - based contact lens with new UV-blocker on vision and driving performance in both daytime and nighttime lighting under real world driving conditions. This will be achieved through field-based driving studies on a closed-road driving circuit at night and during the day. Quantitative methods will be used to assess vision and driving performance under a range of challenging conditions and appropriate masking, order of testing, randomization and control conditions will be used.
Interventions
JJVC senofilcon A-based contact lens with new UV-blocker
DEVICECommercial ACUVUE OASYS
senofilcon A
DEVICECommercial ACUVUE OASYS and Spectacles
Senofilcon A and Spectacles
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. The subject must 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. Between 20 and 49 (inclusive) years of age at the time of screening. 4. Presbyopic subjects must be habitual wearers of distance vision correction in both eyes. 5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D (inclusive) in each eye. 6. The subject's refractive cylinder must be ≤ 1.00 D in each eye. 7. Have spherocylindrical best corrected visual acuity of 20/20 or better in each eye. 8. Be a current soft contact lens wearer in both eyes, defined as at least 5 days per week and 6 hours per day averaged over the past 30 days. 9. Hold a current Open driver's license 10. Be a regular driver (at least once per week) 11. Have at least one year of driving experience
Exclusion criteria
* Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Currently pregnant or lactating 2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study. 3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear, pupil size or accommodation. 4. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion. 5. History of binocular vision abnormality or strabismus 6. Any current use of ocular medication 7. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.) 8. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit lamp biomicroscopy scale 9. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear 10. Employee of clinical site (e.g., Investigator, Coordinator, Technician)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Nighttime Driving Score | 15 Minutes Post Lens Fitting | Overall driving performance score is a composite score calculated as the mean of the Z-scores of the following six driving measures: average sign recognition distance (in meters), percentage of correctly identified sign (\ 42 signs), percentage of hazard avoidance/detection (9 hazards), average pedestrian recognition distance (in meters), lane keeping (percentage of time inside the lane) and the inverse of driving lap time (in seconds).). Equal weighting was assigned to each measure. The individual Z scores were transformed (inverted) such that positive Z scores relate to better performance than the mean. Z scores follow a standard normal distribution (ranging from minus infinity to positive infinity). Overall Z score for night time driving was reported for each study lens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Contrast Threshold Without Glare | 15 Minutes Post Lens Fitting | Binocular contrast sensitivity was assessed under low luminance conditions. Five Landolt C targets in random orientation were presented for each of the four contrast levels 95%, 80%, 63% and 50%. Participants were asked to correctly identify the orientation of the Landolt C. The percentage of subjects that were able to correct identify the orientation of all 5 Landolt's C was reported for each lens type. |
| Percentage of Road Signs Correctly Identified During Night Driving | 15 Minutes Post Lens Fitting | Participants were instructed to report the identity of a percentage of the standard road signs (typically about 42 signs dependent on the route travelled) containing about 65 items of information as they drove around the circuit. The percentage of correctly identified signs was reported for each study lens. |
| Binocular Visual Acuity | 15 Minutes Post Lens Fitting | Binocular visual acuity was assessed under Low luminance (\ 1 lux) high contrast (90%) conditions at a distance of 4 meters. The ETDRS logMAR chart were used, which is scored on a letter by letter basis (-0.02 log units per letter correctly identified). A number of different EDTRS charts was used to reduce potential learning effects. The average LogMAR acuity for each lens was reported. |
| Percentage of Hazards Avoided During Night Driving | 15 Minutes Post Lens Fitting | Participants were required to report and avoid hitting any of nine large, low contrast grey foam hazards (220 cm x 80 cm x 15 cm) positioned orthogonally in the driving lane along the roadway, the locations of which will be randomized between study lenses. The percentage of Hazards avoided for each study lens was reported. |
| Average Pedestrian Recognition Distance | 15 Minutes Post Lens Fitting | The in-vehicle measurement system was utilized to determine the distance at which the participant (as a driver) first recognizes the presence of two pedestrians positioned at the side of the road. An experimenter acted as the pedestrian and walked in-place at the end of a 400 m straight section of roadway which starts and finishes at approximately the same elevation, but features a dip halfway along its length. The pedestrian was not surrounded by any visual clutter or lighting. To reduce expectancy effects, a series of four flashing LEDs and four retro-reflective bollards was positioned around the circuit to increase the instances of flashing lights and retro-reflective material being presented to the driver. The average distance to recognize a pedestrian for each lens type was reported. |
| Average Distance to Correctly Identify Road Signs During Night Driving | 15 Minutes Post Lens Fitting | Measure Description The distance (measured in meters) to recognize a pre-determined road sign was recorded for each subject and lens type at either visit 3 or visit 4, using the in-vehicle measurement system while the participant was driving. The in-vehicle measurement system consisted of a subject pressing a button once the subject was able to recognize the road sign. The average distance in meters was reported for each lens type. Larger distance indicate that a subject was able to identify the pre-determined road sign sooner. |
Countries
Australia
Participant flow
Recruitment details
A total of 24 subjects were enrolled into this study. All enrolled subjects met all eligibility criteria and were dispensed a study lens. Of the dispensed subjects, all 24 completed the study.
Pre-assignment details
A 2X2 William's crossover design was utilized for visit 1. A 3X3 William's Crossover design was utilized for visits 2, 3 and 4.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects that were dispensed at least one study lens. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 29.8 Years STANDARD_DEVIATION 7.71 |
| Race/Ethnicity, Customized Asian | 9 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White | 13 Participants |
| Region of Enrollment Australia | 24 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Primary
Overall Nighttime Driving Score
Overall driving performance score is a composite score calculated as the mean of the Z-scores of the following six driving measures: average sign recognition distance (in meters), percentage of correctly identified sign (\ 42 signs), percentage of hazard avoidance/detection (9 hazards), average pedestrian recognition distance (in meters), lane keeping (percentage of time inside the lane) and the inverse of driving lap time (in seconds).). Equal weighting was assigned to each measure. The individual Z scores were transformed (inverted) such that positive Z scores relate to better performance than the mean. Z scores follow a standard normal distribution (ranging from minus infinity to positive infinity). Overall Z score for night time driving was reported for each study lens.
Time frame: 15 Minutes Post Lens Fitting
Population: All subjects that completed the study without a major protocol violation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Overall Nighttime Driving Score | -0.308 Z-Score | Standard Deviation 0.4718 |
| Control 1 | Overall Nighttime Driving Score | -0.375 Z-Score | Standard Deviation 0.4361 |
| Control 2 | Overall Nighttime Driving Score | -0.430 Z-Score | Standard Deviation 0.4761 |
Comparison: It was calculated that a total of 24 participants was required to show that the Test lens is non-inferior to the control 1 lens with 80% power. Sample size for this study was based on night driving only.95% CI: [-0.045, 0.183]Linear Mixed Model
Secondary
Average Distance to Correctly Identify Road Signs During Night Driving
Measure Description The distance (measured in meters) to recognize a pre-determined road sign was recorded for each subject and lens type at either visit 3 or visit 4, using the in-vehicle measurement system while the participant was driving. The in-vehicle measurement system consisted of a subject pressing a button once the subject was able to recognize the road sign. The average distance in meters was reported for each lens type. Larger distance indicate that a subject was able to identify the pre-determined road sign sooner.
Time frame: 15 Minutes Post Lens Fitting
Population: All subjects that completed the study without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Average Distance to Correctly Identify Road Signs During Night Driving | 110.3 Meters | Standard Deviation 23.45 |
| Control 1 | Average Distance to Correctly Identify Road Signs During Night Driving | 101.5 Meters | Standard Deviation 25.53 |
| Control 2 | Average Distance to Correctly Identify Road Signs During Night Driving | 95.0 Meters | Standard Deviation 22.83 |
95% CI: [7.1, 28.5]Linear Mixed Model
Secondary
Average Pedestrian Recognition Distance
The in-vehicle measurement system was utilized to determine the distance at which the participant (as a driver) first recognizes the presence of two pedestrians positioned at the side of the road. An experimenter acted as the pedestrian and walked in-place at the end of a 400 m straight section of roadway which starts and finishes at approximately the same elevation, but features a dip halfway along its length. The pedestrian was not surrounded by any visual clutter or lighting. To reduce expectancy effects, a series of four flashing LEDs and four retro-reflective bollards was positioned around the circuit to increase the instances of flashing lights and retro-reflective material being presented to the driver. The average distance to recognize a pedestrian for each lens type was reported.
Time frame: 15 Minutes Post Lens Fitting
Population: All subjects that completed the study without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Average Pedestrian Recognition Distance | 208.3 Meters | Standard Deviation 60.46 |
| Control 1 | Average Pedestrian Recognition Distance | 201.1 Meters | Standard Deviation 62.92 |
| Control 2 | Average Pedestrian Recognition Distance | 195.5 Meters | Standard Deviation 60.7 |
95% CI: [-11.4, 20.7]Linear Mixed Model
Secondary
Binocular Contrast Threshold Without Glare
Binocular contrast sensitivity was assessed under low luminance conditions. Five Landolt C targets in random orientation were presented for each of the four contrast levels 95%, 80%, 63% and 50%. Participants were asked to correctly identify the orientation of the Landolt C. The percentage of subjects that were able to correct identify the orientation of all 5 Landolt's C was reported for each lens type.
Time frame: 15 Minutes Post Lens Fitting
Population: All subjects that completed the study without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Binocular Contrast Threshold Without Glare | 50% | 87.5 Percentage of Participants |
| Test | Binocular Contrast Threshold Without Glare | 95% Contrast | 100 Percentage of Participants |
| Test | Binocular Contrast Threshold Without Glare | 80% Contrast | 100 Percentage of Participants |
| Test | Binocular Contrast Threshold Without Glare | 63% Contrast | 91.7 Percentage of Participants |
| Control 1 | Binocular Contrast Threshold Without Glare | 63% Contrast | 91.7 Percentage of Participants |
| Control 1 | Binocular Contrast Threshold Without Glare | 50% | 75.0 Percentage of Participants |
| Control 1 | Binocular Contrast Threshold Without Glare | 80% Contrast | 95.8 Percentage of Participants |
| Control 1 | Binocular Contrast Threshold Without Glare | 95% Contrast | 100 Percentage of Participants |
| Control 2 | Binocular Contrast Threshold Without Glare | 63% Contrast | 87.5 Percentage of Participants |
| Control 2 | Binocular Contrast Threshold Without Glare | 95% Contrast | 100 Percentage of Participants |
| Control 2 | Binocular Contrast Threshold Without Glare | 80% Contrast | 95.8 Percentage of Participants |
| Control 2 | Binocular Contrast Threshold Without Glare | 50% | 58.3 Percentage of Participants |
95% CI: [0.442, 22.604]Generalized Estimating Equation
Secondary
Binocular Visual Acuity
Binocular visual acuity was assessed under Low luminance (\ 1 lux) high contrast (90%) conditions at a distance of 4 meters. The ETDRS logMAR chart were used, which is scored on a letter by letter basis (-0.02 log units per letter correctly identified). A number of different EDTRS charts was used to reduce potential learning effects. The average LogMAR acuity for each lens was reported.
Time frame: 15 Minutes Post Lens Fitting
Population: All subjects that completed the study without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Binocular Visual Acuity | 0.251 logMAR | Standard Deviation 0.0722 |
| Control 1 | Binocular Visual Acuity | 0.273 logMAR | Standard Deviation 0.0705 |
| Control 2 | Binocular Visual Acuity | 0.298 logMAR | Standard Deviation 0.0739 |
95% CI: [-0.043, -0.012]Linear Mixed Model
Secondary
Percentage of Hazards Avoided During Night Driving
Participants were required to report and avoid hitting any of nine large, low contrast grey foam hazards (220 cm x 80 cm x 15 cm) positioned orthogonally in the driving lane along the roadway, the locations of which will be randomized between study lenses. The percentage of Hazards avoided for each study lens was reported.
Time frame: 15 Minutes Post Lens Fitting
Population: All subjects that completed the study without a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Percentage of Hazards Avoided During Night Driving | 95.4 Percentage of Participants |
| Control 1 | Percentage of Hazards Avoided During Night Driving | 95.4 Percentage of Participants |
| Control 2 | Percentage of Hazards Avoided During Night Driving | 93.1 Percentage of Participants |
95% CI: [0.33, 1.74]Generalized Linear Mixed Model
Secondary
Percentage of Road Signs Correctly Identified During Night Driving
Participants were instructed to report the identity of a percentage of the standard road signs (typically about 42 signs dependent on the route travelled) containing about 65 items of information as they drove around the circuit. The percentage of correctly identified signs was reported for each study lens.
Time frame: 15 Minutes Post Lens Fitting
Population: All subjects that completed the study without a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Percentage of Road Signs Correctly Identified During Night Driving | 72.7 Percentage of participants |
| Control 1 | Percentage of Road Signs Correctly Identified During Night Driving | 73.3 Percentage of participants |
| Control 2 | Percentage of Road Signs Correctly Identified During Night Driving | 73.3 Percentage of participants |
95% CI: [0.82, 1.16]Generalized Linear Mixed Model