NCT02543528

A Clinical Trial to Evaluate Investigational Silicone Hydrogel Contact Lenses Worn Continuously for One Week

Echo Ionic Silicone Hydrogel 6-Month Extended Wear Investigation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Johnson & Johnson Vision Care, Inc. · Industry
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group clinical trial design. All subjects will participate in a 2-week daily disposable contact lens adaptation period prior to being randomized into one of the four extended wear lenses. The study has a total of 9 scheduled study visits and a total duration of \~197 days. The lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.

Conditions

• Visual Disorder

Interventions

Type	Name	Description
DEVICE	Investigational Lens 1	One fresh pair of Investigational Lens 1 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
DEVICE	Investigational Lens 2	One fresh pair of Investigational Lens 2 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
DEVICE	Investigational Lens 3	One fresh pair of Investigational Lens 3 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
DEVICE	etafilcon A (Reusable)	One fresh pair of etafilcon A (Reusable) contact lenses worn continuously in 6nights/7 days wear cycles for 6 months of total wear.
DEVICE	etafilcon A (1-Day)	2-week contact lens adaptation period wearing prior to randomization

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-11-08
• Completion: 2016-11-08
• First posted: 2015-09-07
• Last updated: 2019-10-01
• Results posted: 2018-03-29

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated device study