Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-25 @ 10:03 PM
Study NCT ID:
NCT02719366
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2016-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
Sponsor:
CooperVision, Inc.
Organization:
Study Overview
Official Title:
A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
Status:
COMPLETED
Status Verified Date:
2020-07
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 aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.
Detailed Description:
This study is a 20-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: