Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00357383
Status:
COMPLETED
Last Update Posted:
2006-07-27
First Post:
2006-07-25
Brief Title:
Study of the Ocular Safety After Repeated Instillations of T1225 1 or 15 Eye Drops in Healthy Volunteers
Sponsor:
Laboratoires Thea
Organization:
Laboratoires Thea
Study Overview
Official Title:
Study of the Ocular Safety After Repeated Instillations of T1225 1 or 15 Eye Drops in Healthy Volunteers
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 evaluate the ocular tolerance of T1225 1 and 15 eye drops versus vehicle after one instillation twice-daily morning and evening in one eye during 3 days from Day 0 to Day 2
To assess azithromycin tear conjunctiva and plasmatic concentrations after a 3-day treatment period
To assess azithromycin tear conjunctiva and plasmatic concentrations after a 3-day treatment period
Detailed Description:
The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1 and 15 eye drops and vehicle and to assess the residual azithromycin concentrations in tear ocular conjunctiva and plasma samples approximately 12 hours after the last Investigational Medicinal Product instillation
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