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

NCT03330275 | Completed Phase 2 Results FDA Device

• 1 other identifier: CR-5830
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Performance

Outcome Measures

Primary Outcomes (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.

  15 Minutes Post Lens Fitting

Secondary Outcomes (6)

• Binocular Visual Acuity

  15 Minutes Post Lens Fitting

• Binocular Contrast Threshold Without Glare

  15 Minutes Post Lens Fitting

• Percentage of Road Signs Correctly Identified During Night Driving

  15 Minutes Post Lens Fitting

• Average Distance to Correctly Identify Road Signs During Night Driving

  15 Minutes Post Lens Fitting

• Percentage of Hazards Avoided During Night Driving

  15 Minutes Post Lens Fitting

Study Arms (6)

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.

Device: Investigational Contact Lens; Device: Commercial ACUVUE OASYS; Device: Commercial ACUVUE OASYS and Spectacles

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.

Device: Investigational Contact Lens; Device: Commercial ACUVUE OASYS; Device: Commercial ACUVUE OASYS and Spectacles

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.

Device: Investigational Contact Lens; Device: Commercial ACUVUE OASYS; Device: Commercial ACUVUE OASYS and Spectacles

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.

Device: Investigational Contact Lens; Device: Commercial ACUVUE OASYS; Device: Commercial ACUVUE OASYS and Spectacles

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.

Device: Investigational Contact Lens; Device: Commercial ACUVUE OASYS; Device: Commercial ACUVUE OASYS and Spectacles

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.

Device: Investigational Contact Lens; Device: Commercial ACUVUE OASYS; Device: Commercial ACUVUE OASYS and Spectacles

Interventions

Investigational Contact Lens DEVICE

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

Also known as: Test

Control 1/Control 2/Test; Control 1/Test/Control 2; Control 2/Control 1/Test; Control 2/Test/Control 1; Test/Control 1/Control 2; Test/Control 2/Control 1

Commercial ACUVUE OASYS DEVICE

senofilcon A

Also known as: Control 1

Control 1/Control 2/Test; Control 1/Test/Control 2; Control 2/Control 1/Test; Control 2/Test/Control 1; Test/Control 1/Control 2; Test/Control 2/Control 1

Commercial ACUVUE OASYS and Spectacles DEVICE

Senofilcon A and Spectacles

Also known as: Control 2

Control 1/Control 2/Test; Control 1/Test/Control 2; Control 2/Control 1/Test; Control 2/Test/Control 1; Test/Control 1/Control 2; Test/Control 2/Control 1

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Queensland University of Technology, School of Optometry and Vision Science

Brisbane, Queensland, Australia

Location

Related Publications (1)

• 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.

  PMID: 31895273 DERIVED

MeSH Terms

Interventions

Eyeglasses

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: John Buch- SENIOR PRINCIPAL RESEARCH OPTOMETRIST
• Organization: Johnson & Johnson Vision Care, Inc.

JBUCH@its.jnj.com

904 443-1707

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: November 6, 2017
• Study Start: September 27, 2017
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: August 7, 2018
• Results First Posted: August 7, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)