Status:
COMPLETED
Evaluating the Impact of JJVC Senofilcon A - Based Contact Lens With New UV-blocker on Day and Night Driving Performance
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Visual Performance
Eligibility:
All Genders
20-49 years
Phase:
PHASE2
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 - bas...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03330275
Start Date
September 27 2017
End Date
December 11 2017
Last Update
August 7 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Queensland University of Technology, School of Optometry and Vision Science
Brisbane, Queensland, Australia