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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control 1/Control 2 | Experimental | Subjects will be randomized to 1 of 3 lenses (Test/Control 1/Control 2). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route. |
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| Test/Control 2/Control 1 | Experimental | Subjects will be randomized to 1 of 3 lenses (Test/Control 2/Control 1). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route. |
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| Control 1/Test/Control 2 | Experimental | Subjects will be randomized to 1 of 3 lenses (Control 1/Test/Control 2). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route. |
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| Control 1/Control 2/Test | Experimental | Subjects will be randomized to 1 of 3 lenses (Control 1/Control 2/Test). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Contact Lens | Device | JJVC senofilcon A-based contact lens with new UV-blocker |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 Minutes Post Lens Fitting |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Between 20 and 49 (inclusive) years of age at the time of screening.
Presbyopic subjects must be habitual wearers of distance vision correction in both eyes.
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.
The subject's refractive cylinder must be ≤ 1.00 D in each eye.
Have spherocylindrical best corrected visual acuity of 20/20 or better in each eye.
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.
Hold a current Open driver's license
Be a regular driver (at least once per week)
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queensland University of Technology, School of Optometry and Vision Science | Brisbane | Queensland | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31895273 | Derived | Buch JR, Toubouti Y, Cannon J. Randomized Crossover Trial Evaluating the Impact of Senofilcon A Photochromic Lens on Driving Performance. Optom Vis Sci. 2020 Jan;97(1):15-23. doi: 10.1097/OPX.0000000000001466. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control1 | Subjects that were randomized to receive the Test lens during period 1 of visit 1 and the Control 1 lens during period 2 of visit 1. |
| FG001 | Control1/Test | Subjects that were randomized to receive the Control 1 lens during period 1 of visit 1 and the Test lens during period 2 of visit 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Visit 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 | Yes | No | No | Study Protocol | Sep 14, 2017 | May 7, 2018 |
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| Control 2/Test/Control 1 | Experimental | Subjects will be randomized to 1 of 3 lenses (Control 2/Test/Control 1). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route. |
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| Control 2/Control 1/Test | Experimental | Subjects will be randomized to 1 of 3 lenses (Control 2/Control 1/Test). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route. |
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| Commercial ACUVUE OASYS | Device | senofilcon A |
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| Commercial ACUVUE OASYS and Spectacles | Device | Senofilcon A and Spectacles |
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| 15 Minutes Post Lens Fitting |
| 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. | 15 Minutes Post Lens Fitting |
| 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. | 15 Minutes Post Lens Fitting |
| 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. | 15 Minutes Post Lens Fitting |
| 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. | 15 Minutes Post Lens Fitting |
| 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. | 15 Minutes Post Lens Fitting |
| FG002 | Test/Control2 | Subjects that were randomized to receive the Test lens during period 1 of visit 1 and the Control 2 lens during period 2 of visit 1. |
| FG003 | Control2/Test | Subjects that were randomized to receive the Control 2 lens during period 1 of visit 1 and the Test lens during period 2 of visit 1. |
| FG004 | Test/Control1/Control2 | Subjects that were randomized to receive the Test lens during period 1, the Control 1 lens during period 2 and the Control 2 lens during period 3. This applies to visits 2, 3 and 4. |
| FG005 | Test/Control2/Control1 | Subjects that were randomized to receive the Test lens during period 1, the Control 2 lens during period 2 and the Control 1 lens during period 3. This applies to visits 2, 3 and 4. |
| FG006 | Control1/Control2/Test | Subjects that were randomized to receive the Control 1 lens during period 1, the Control 2 lens during period 2 and the Test lens during period 3. This applies to visits 2, 3 and 4. |
| FG007 | Control1/Test/Control2 | Subjects that were randomized to receive the Control 1 lens during period 1, the Test lens during period 2 and the Control 2 lens during period 3. This applies to visits 2, 3 and 4. |
| FG008 | Control2/Control1/Test | Subjects that were randomized to receive the Control 2 lens during period 1, the Control 1 lens during period 2 and the Test lens during period 3. This applies to visits 2, 3 and 4. |
| FG009 | Control2/Test/Control1 | Subjects that were randomized to receive the Control 2 lens during period 1, the Test lens during period 2 and the Control 1 lens during period 3. This applies to visits 2, 3 and 4. |
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| NOT COMPLETED |
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| Visit 1 - Period 2 |
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| Visits 2, 3 and 4 - Period 1 |
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| Visits 2, 3 and 4 - Period 2 |
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| Visits 2, 3 and 4 - Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects that were dispensed at least one study lens. |
| Units | Counts |
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| 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 | 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 | 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. | All subjects that completed the study without a major protocol violation. | Posted | Mean | Standard Deviation | Z-Score | 15 Minutes Post Lens Fitting |
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| 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. | All subjects that completed the study without a major protocol deviation. | Posted | Mean | Standard Deviation | logMAR | 15 Minutes Post Lens Fitting |
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| 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. | All subjects that completed the study without a major protocol deviation. | Posted | Number | Percentage of Participants | 15 Minutes Post Lens Fitting |
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| 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. | All subjects that completed the study without a major protocol deviation. | Posted | Number | Percentage of participants | 15 Minutes Post Lens Fitting |
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| 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. | All subjects that completed the study without a major protocol deviation. | Posted | Mean | Standard Deviation | Meters | 15 Minutes Post Lens Fitting |
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| 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. | All subjects that completed the study without a major protocol deviation. | Posted | Number | Percentage of Participants | 15 Minutes Post Lens Fitting |
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| 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. | All subjects that completed the study without a major protocol deviation. | Posted | Mean | Standard Deviation | Meters | 15 Minutes Post Lens Fitting |
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Throughout the entire duration of the study. Approximately 2 weeks per subject.
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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 | Control 1 | Subjects that wore the Control 1 lens at any point in the study. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG001 | Control 2 | Subjects that wore the Control lens at any point in the study. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Test | Subjects that wore the Test lens at any point in the study. | 0 | 24 | 0 | 24 | 0 | 24 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Buch- SENIOR PRINCIPAL RESEARCH OPTOMETRIST | Johnson & Johnson Vision Care, Inc. | 904 443-1707 | JBUCH@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 26, 2017 | May 7, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Other |
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A non-inferiority margin of -0.25 was used. Non-inferioirty was concluded if the lower limit of the 95% CI was above 0.25.
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| Participants |
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Subjects that wore the Control 2 lens during any of the three study periods at either visit 3 or visit 4. |
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