Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT05166902
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2021-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use
Sponsor:
CooperVision, Inc.
Organization:
Study Overview
Official Title:
Evaluation of Monthly Replacement Lens Designs in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use
Status:
COMPLETED
Status Verified Date:
2022-05
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:
To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-month.
Detailed Description:
This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different FRP lens types. Each lens type will be worn for approximately one month.
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?: