Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588400
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
AOSEPT CLEAR CARE PLUS Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
AOSEPT PLUS With HydraGlyde FID 120947A and AOCup Lens Case CLEAR CARE PLUS and AOSEPT PLUS FID 119056 and AOCup Lens Case CLEAR CARE Family PMCF Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this post-market clinical follow-up PMCF study is to evaluate the long-term safety and performance of 2 commercially available contact lens cleaning and disinfecting systems in a pediatric population
Detailed Description:
Subjects will participate in the study for approximately 90 days with telephone calls scheduled on Day 30 7 Visit 2 and Day 60 7 Visit 3 and an in-office follow-up visit scheduled on Day 90 7 Visit 4 Subjects may have unscheduled visits if deemed necessary per the Investigators judgment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None