NCT02701556

A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 396 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and effectiveness of NNR06 Multi-Purpose Solution cleaning and disinfecting solution (Test) compared to COMPLETE Multi-Purpose Solution cleaning and disinfecting solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximately three months.

Detailed description

Approximately 398 subjects (796 eyes) will be enrolled in this three-month controlled, parallel group, masked, randomized study at approximately 22 investigative sites in the United States (US). Approximately one-half of the subjects will be randomized to receive Bausch \& Lomb investigational NNR06 Multi-Purpose Solution to be used with a rub care regimen (Test), and approximately one-half of the subjects will be randomized to receive COMPLETE Multi-Purpose Solution with a rub care regimen (Control).

Conditions

• Contact Lens Wear

Interventions

Type	Name	Description
DEVICE	Complete MPS	a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
DEVICE	NNR06	an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.

Timeline

• Start date: 2015-05-31
• Primary completion: 2015-10-31
• Completion: 2015-10-31
• First posted: 2016-03-08
• Last updated: 2022-02-08
• Results posted: 2017-05-31

Locations

1 site across 1 country: United States