Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-31 @ 6:37 AM
Study NCT ID:
NCT02701556
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2015-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution
Sponsor:
Bausch & Lomb Incorporated
Organization:
Study Overview
Official Title:
A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: