Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00357773
Status:
COMPLETED
Last Update Posted:
2006-07-27
First Post:
2006-07-25
Brief Title:
Efficacy and Safety of T1225 15 Versus Tobramycin 03 in the Treatment of Purulent Bacterial Conjunctivitis
Sponsor:
Laboratoires Thea
Organization:
Laboratoires Thea
Study Overview
Official Title:
Clinical Efficacy and Safety of T1225 15 Eye Drops 3-Day Treatment Versus Tobramycin 03 Eye Drops 7-Day Treatment in the Treatment of Purulent Bacterial Conjunctivitis
Status:
COMPLETED
Status Verified Date:
2006-07
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 demonstrate the efficacy of T1225 15 eye drops in comparison to reference product for the treatment of purulent bacterial conjunctivitis and to assess the safety
Detailed Description:
The aim of the present study was to compare the efficacy and safety of T1225 15 eye drops administered BID for 3 days in comparison to reference antibiotic eye drops tobramycin for the treatment of purulent bacterial conjunctivitis The study was conducted as a Phase III multicentre international investigator-masked randomised parallel-group non-inferiority study in newborns children and adults
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