Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT03605303
Status:
TERMINATED
Last Update Posted:
2019-08-28
First Post:
2018-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process
Sponsor:
Johnson & Johnson Vision Care, Inc.
Organization:
Study Overview
Official Title:
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process
Status:
TERMINATED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated due to the released lenses not representing what will be made commercially available and thus the objectives could not be met
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.
Detailed Description:
None
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?: