Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT03372551
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2017-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens
Sponsor:
CooperVision, Inc.
Organization:
Study Overview
Official Title:
Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses
Status:
COMPLETED
Status Verified Date:
2019-07
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 purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.
Detailed Description:
The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: