NCT03208088

Clinical Evaluation of Multifocal Toric Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Johnson & Johnson Vision Care, Inc. · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a double-masked, bilateral, randomized, non-dispensing clinical trial. The study lenses will be worn in a bilateral and random fashion using a 5x5 crossover Williams design with 5 lens types and 5 periods. The subjects will wear each pair of lenses for approximately 15 minutes with a 15 minute wash-out between each pair. Two lens types will be fit at the first visit and three lens types will be fit at the second visit. Using a computer-generated randomization scheme, each subject will randomly be assigned to 1 of 10 unique sequences of the 5 lens types. Randomization will be stratified by site.

Conditions

• Visual Acuity

Interventions

Type	Name	Description
DEVICE	etafilcon A Investigational Toric Multifocal Contact Lens	Test Lens 1
DEVICE	etafilcon A Investigational Toric Multifocal Contact Lens	Test Lens 2
DEVICE	etafilcon A Investigational Toric Multifocal Contact Lens	Tes Lens 3
DEVICE	etafilcon A Investigational Toric Multifocal Contact Lens	Test Lens 4
DEVICE	etafilcon A Investigational Toric Multifocal Contact Lens	Control Lens

Timeline

• Start date: 2017-06-12
• Primary completion: 2017-07-21
• Completion: 2017-07-21
• First posted: 2017-07-05
• Last updated: 2020-09-10
• Results posted: 2020-09-10

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study