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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Timepoint [1] 0 0
15 Minutes Post Lens Fitting
Secondary outcome [1] 0 0
Binocular Visual Acuity
Timepoint [1] 0 0
15 Minutes Post Lens Fitting
Secondary outcome [2] 0 0
Binocular Contrast Threshold Without Glare
Timepoint [2] 0 0
15 Minutes Post Lens Fitting
Secondary outcome [3] 0 0
Percentage of Road Signs Correctly Identified During Night Driving
Timepoint [3] 0 0
15 Minutes Post Lens Fitting
Secondary outcome [4] 0 0
Average Distance to Correctly Identify Road Signs During Night Driving
Timepoint [4] 0 0
15 Minutes Post Lens Fitting
Secondary outcome [5] 0 0
Percentage of Hazards Avoided During Night Driving
Timepoint [5] 0 0
15 Minutes Post Lens Fitting
Secondary outcome [6] 0 0
Average Pedestrian Recognition Distance
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
Sex
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
27/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/12/2017
Sample size
Target
Accrual to date
Final
24
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/ct2/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