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Phase 2 N=24 Randomized Single-blind Treatment

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

Visual Performance

Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Overall Nighttime Driving Score — -0.308; -0.375; -0.430 Z-Score

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Investigational Contact Lens (Device); Commercial ACUVUE OASYS (Device); Commercial ACUVUE OASYS and Spectacles (Device)
Age
Adult · 20+ yrs
Sex
All
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Nighttime Driving Score
-0.308; -0.375; -0.430
SECONDARY
Binocular Visual Acuity
0.251; 0.273; 0.298
SECONDARY
Binocular Contrast Threshold Without Glare
100; 100; 100; 100; 95.8; 95.8
SECONDARY
Percentage of Road Signs Correctly Identified During Night Driving
72.7; 73.3; 73.3
SECONDARY
Average Distance to Correctly Identify Road Signs During Night Driving
110.3; 101.5; 95.0
SECONDARY
Percentage of Hazards Avoided During Night Driving
95.4; 95.4; 93.1
SECONDARY
Average Pedestrian Recognition Distance
208.3; 201.1; 195.5

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.

Eligibility Criteria

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:
  • 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03330275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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