NCT03228212

Evaluation of Approved and Investigational Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Johnson & Johnson Vision Care, Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover, dispensing clinical trial. During the study, each test article will be worn in a daily wear modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The subject will wear either the Test or Control article twice and the other study article once. The primary objective of this study is to demonstrate that the Test lens works as well, if not better compared to the Control lens with respect to CLUE (Contact Lens User Experience) comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will also aim to show acceptable lens fit for subjects wearing the Test lens.

Conditions

• Visual Acuity

Interventions

Type	Name	Description
DEVICE	CONTROL	ACUVUE OASYS
DEVICE	TEST	senofilcon A with new UV blocker

Timeline

• Start date: 2017-07-14
• Primary completion: 2017-09-18
• Completion: 2017-09-18
• First posted: 2017-07-24
• Last updated: 2018-12-13
• Results posted: 2018-12-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study