Ignite Creation Date:
2024-05-06 @ 12:20 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03739528
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2018-11-09
Brief Title:
Levo-Dexa vs TobraDexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
Sponsor:
NTC srl
Organization:
NTC srl
Study Overview
Official Title:
An International Multicenter Randomized Blinded-assessor Parallel-group Clinical Study Comparing Eye Drops of Combined LEvofloxAcin DExamethasone foR 7 Days Followed by Dexamethasone Alone for an Additional 7 Days vs Tobramycin Dexamethasone for 14 Days for the Prevention and Treatment of Inflammation and Prevention of Infection Associated With Cataract Surgery in Adults - LEADER 7
Status:
COMPLETED
Status Verified Date:
2020-08
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:
LEADER7
Brief Summary:
The purpose of this study is to demonstrate the non-inferiority of the study treatment combined levofloxacin dexamethasone eye drops followed by dexamethasone eye drops alone vs standard treatment in the prevention and treatment of postoperative ocular inflammation and prevention of infection
Detailed Description:
In clinical practice topical treatment following cataract surgery is frequently administered using a combination between an antibiotic and a corticosteroid to promote patient adherence to therapy and to obtain both prevention of infection and treatment of post-surgical inflammation
The combination of tobramycin and dexamethasone is among the most widely used combinations however treatment duration and the need for tapering posology over several weeks may favour the development of bacterial resistance The study treatment associating a broad-spectrum antibiotic with a highly effective corticosteroid that can be used for a short period of time one week is therefore of considerable interest
The aim of this study is to evaluate the non-inferiority of the study treatment used for a limited period of time and followed by dexamethasone alone compared to standard treatment in preventing and treating ocular inflammation and in preventing post-operative infection while limiting the emergence of antibiotic resistance
The combination of tobramycin and dexamethasone is among the most widely used combinations however treatment duration and the need for tapering posology over several weeks may favour the development of bacterial resistance The study treatment associating a broad-spectrum antibiotic with a highly effective corticosteroid that can be used for a short period of time one week is therefore of considerable interest
The aim of this study is to evaluate the non-inferiority of the study treatment used for a limited period of time and followed by dexamethasone alone compared to standard treatment in preventing and treating ocular inflammation and in preventing post-operative infection while limiting the emergence of antibiotic resistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None