NCT03330275

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Johnson & Johnson Vision Care, Inc. · Industry
• Sex: All
• Age: 20 Years – 49 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Investigational Contact Lens	JJVC senofilcon A-based contact lens with new UV-blocker
DEVICE	Commercial ACUVUE OASYS	senofilcon A
DEVICE	Commercial ACUVUE OASYS and Spectacles	Senofilcon A and Spectacles

Timeline

• Start date: 2017-09-27
• Primary completion: 2017-12-11
• Completion: 2017-12-11
• First posted: 2017-11-06
• Last updated: 2018-08-07
• Results posted: 2018-08-07

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study