Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06119191
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2023-10-31
Brief Title:
Clinical Evaluation of Reusable Soft Contact Lenses
Sponsor:
Coopervision Inc
Organization:
Coopervision Inc
Study Overview
Official Title:
Clinical Evaluation of Comfilcon A Contact Lenses
Status:
COMPLETED
Status Verified Date:
2023-10
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 confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers
Detailed Description:
This will be a prospective multiple day double investigator and subject-masked randomized bilateral re-fit parallel arm study comparing Test lenses against appropriate Control lenses Participants will be randomized to wear either the Test or Control lenses and the estimated duration of involvement is 4 months
Study Oversight
Has Oversight DMC:
None
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?:
None