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Visual PerformancePhase 2NCT03330275

Evaluating the Impact of JJVC Senofilcon A - Based Contact Lens With New UV-blocker on Day and Night Driving Performance

A Phase 2 study testing Investigational Contact Lens, Commercial ACUVUE OASYS and Commercial ACUVUE OASYS and Spectacles in people with Visual Performance, run by Johnson & Johnson Vision Care, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Visual Performance
What is being tested?
Investigational Contact Lens, Commercial ACUVUE OASYS and Commercial ACUVUE OASYS and Spectacles
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteAustralia
Study dates
27 Sep 2017to 11 Dec 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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

Who cannot join

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:
  • Currently pregnant or lactating
  • 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.
  • Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear, pupil size or accommodation.
  • 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.
  • History of binocular vision abnormality or strabismus
Show all 11Show fewer
  • Any current use of ocular medication
  • Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
  • 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
  • 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
  • Employee of clinical site (e.g., Investigator, Coordinator, Technician)

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Queensland University of Technology, School of Optometry and Vision Science

    Brisbane, Queensland

Other trials in Australia

About this study

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.

Being tested
Investigational Contact Lens, Commercial ACUVUE OASYS, Commercial ACUVUE OASYS and Spectacles

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Investigational Contact LensDevice

    Also called Test

    JJVC senofilcon A-based contact lens with new UV-blocker

  • Commercial ACUVUE OASYSDevice

    Also called Control 1

    senofilcon A

  • Commercial ACUVUE OASYS and SpectaclesDevice

    Also called Control 2

    Senofilcon A and Spectacles

Study groups in NCT03330275
Study groupRoleWhat they receive
Test/Control 1/Control 2ExperimentalSubjects 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.
Receives: Device: Investigational Contact Lens; Device: Commercial ACUVUE OASYS; Device: Commercial ACUVUE OASYS and Spectacles
Test/Control 2/Control 1ExperimentalSubjects 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.
Receives: Device: Investigational Contact Lens; Device: Commercial ACUVUE OASYS; Device: Commercial ACUVUE OASYS and Spectacles
Control 1/Test/Control 2ExperimentalSubjects 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.
Receives: Device: Investigational Contact Lens; Device: Commercial ACUVUE OASYS; Device: Commercial ACUVUE OASYS and Spectacles
Control 1/Control 2/TestExperimentalSubjects 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.
Receives: Device: Investigational Contact Lens; Device: Commercial ACUVUE OASYS; Device: Commercial ACUVUE OASYS and Spectacles
Control 2/Test/Control 1ExperimentalSubjects 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.
Receives: Device: Investigational Contact Lens; Device: Commercial ACUVUE OASYS; Device: Commercial ACUVUE OASYS and Spectacles
Control 2/Control 1/TestExperimentalSubjects 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.
Receives: Device: Investigational Contact Lens; Device: Commercial ACUVUE OASYS; Device: Commercial ACUVUE OASYS and Spectacles

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 15 Minutes Post Lens Fitting

Secondary outcomes (6)

  1. 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.

    Measured: 15 Minutes Post Lens Fitting

  2. 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.

    Measured: 15 Minutes Post Lens Fitting

  3. 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.

    Measured: 15 Minutes Post Lens Fitting

  4. 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.

    Measured: 15 Minutes Post Lens Fitting

  5. 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.

    Measured: 15 Minutes Post Lens Fitting

  6. 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.

    Measured: 15 Minutes Post Lens Fitting

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start27 Sep 2017
  3. Primary completion11 Dec 2017
  4. Study completion11 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03330275
Sponsor's protocol ID
CR-5830
Status last verified
Jul 2018
First submitted
17 Oct 2017
Last updated
7 Aug 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 31895273

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Investigational Contact Lens, Commercial ACUVUE OASYS and Commercial ACUVUE OASYS and Spectacles in people with Visual Performance, run by Johnson & Johnson Vision Care, Inc. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Nighttime Driving Score (time frame: 15 Minutes Post Lens Fitting). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03330275, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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