Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429306
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-05-11
Brief Title:
Study of Dexycu in Treating Intraocular Inflammation
Sponsor:
Ocumension Therapeutics Shanghai Co Ltd
Organization:
Ocumension Therapeutics Suzhou Co Ltd
Study Overview
Official Title:
A Phase 3Prospective Randomized Double-masked Placebo-controlled Parallel Study to Evaluate the Efficacy PK and Safety of 9 Dexamethasone Intraocular Injection for the Treatment of Inflammation Associatedwith Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2024-08
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:
None
Brief Summary:
This is a phase III prospective randomised double-masked placebo-controlled parallel-design multicenter study of the efficacy safety and pharmacokinetics of 9 dexamethasone intraocular injection for the treatment of inflammation associated with cataract surgery
Detailed Description:
This is a prospective randomized double-blindmasked placebo-controlled parallel- design multicenter study of subjects over 40 years undergoing cataract surgery Subjects meet the inclusion criteria and do not meet any exclusion criteria are randomiszed to the dexamethasone implant group or placebo group at a ratio of 21
Subjects received a single does injection in the study eye immediately after the completion of cataract surgery The investigational drug comes with a special injection device and injection guide
All subjects will be administered to the study eye with quinolone topical antibiotic eye drops or their equivalent 3 days before and 7 days after surgery
Subjects received a single does injection in the study eye immediately after the completion of cataract surgery The investigational drug comes with a special injection device and injection guide
All subjects will be administered to the study eye with quinolone topical antibiotic eye drops or their equivalent 3 days before and 7 days after surgery
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