COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03330275




Registration number
NCT03330275
Ethics application status
Date submitted
17/10/2017
Date registered
6/11/2017
Date last updated
7/08/2018

Titles & IDs
Public title
Evaluating the Impact of JJVC Senofilcon A - Based Contact Lens With New UV-blocker on Day and Night Driving Performance
Scientific title
Evaluating the Impact of JJVC Senofilcon A - Based Contact Lens With New UV-blocker on Day and Night Driving Performance
Secondary ID [1] 0 0
CR-5830
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Visual Performance 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Investigational Contact Lens
Treatment: Devices - Commercial ACUVUE OASYS
Treatment: Devices - Commercial ACUVUE OASYS and Spectacles

Experimental: Test/Control 1/Control 2 - 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.

Experimental: Test/Control 2/Control 1 - 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.

Experimental: Control 1/Test/Control 2 - 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.

Experimental: Control 1/Control 2/Test - 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.

Experimental: Control 2/Test/Control 1 - 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.

Experimental: Control 2/Control 1/Test - 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.


Treatment: Devices: Investigational Contact Lens
JJVC senofilcon A-based contact lens with new UV-blocker

Treatment: Devices: Commercial ACUVUE OASYS
senofilcon A

Treatment: Devices: Commercial ACUVUE OASYS and Spectacles
Senofilcon A and Spectacles

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
15 Minutes Post Lens Fitting
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
15 Minutes Post Lens Fitting
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
15 Minutes Post Lens Fitting
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
15 Minutes Post Lens Fitting
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
15 Minutes Post Lens Fitting
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
15 Minutes Post Lens Fitting
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
15 Minutes Post Lens Fitting

Eligibility
Key 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
Minimum age
20 Years
Maximum age
49 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queensland University of Technology, School of Optometry and Vision Science - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Johnson & Johnson Vision Care, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03330275
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications