Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533995
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
The Usefulness of Visuprime in Cataract Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Performance of Visuprime in Improving Ocular Surface Homeostasis and Reducing Conjunctival Bacterial Load in Patients Receiving Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2024-07
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:
This is a multicentre post-market open label randomized placebo-controlled prospective study exploring the performance of Visuprime in improving ocular surface homeostasis and reducing conjunctival bacterial load in patients receiving cataract surgery as an addon treatment to postoperative standard terapy The study will consist on 3 visits Visit 1 day -3 from surgery Visit 2 day 0 surgery and Visit 3 day 7 from surgery Patients will be enrolled after having signed the informed consent form prior to any other study procedure and after inclusionexclusion criteria check At each visit all study procedures will be performed according to the clinical investigation plan requirements Patients will be enrolled at Visit 1 and randomized with a 11 ratio to 2 groups
GROUP A patients receiving Visuprime eyedrop BID from day -3 to week 1 After surgery patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop levofloxacin eyedrop both given four times daily QID from day 0 after surgery to the end of the study
GROUP B patients receiving placebo eyedrop the vehicle of Visuprime ie isotonic buffered saline solution BID from day -3 to week 1
After surgery patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop QID levofloxacin eyedrop QID from day 0 to the end of the study
GROUP A patients receiving Visuprime eyedrop BID from day -3 to week 1 After surgery patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop levofloxacin eyedrop both given four times daily QID from day 0 after surgery to the end of the study
GROUP B patients receiving placebo eyedrop the vehicle of Visuprime ie isotonic buffered saline solution BID from day -3 to week 1
After surgery patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop QID levofloxacin eyedrop QID from day 0 to the end of the study
Detailed Description:
None
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