Evaluating the Impact of JJVC Senofilcon A - Based Contact Lens With New UV-blocker on Day and Night Driving Performance
Condition: Visual Performance
Intervention: Investigational Contact Lens; Commercial ACUVUE OASYS; Commercial ACUVUE OASYS and Spectacles
Intervention description: JJVC senofilcon A-based contact lens with new UV-blocker; senofilcon A; Senofilcon A and Spectacles
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 24.0
Sex: All
Minimum age: 20 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

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:

               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

                  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)