Ignite Creation Date:
2024-05-06 @ 8:37 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02770248
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2016-05-11
Brief Title:
24-hr Intraocular Pressure Control With SIMBRINZA
Sponsor:
Alcon Research
Organization:
Alcon Research
Study Overview
Official Title:
24-hr Intraocular Pressure Control With Brinzolamide 1 Brimonidine 02 Ophthalmic Suspension vs Vehicle
Status:
COMPLETED
Status Verified Date:
2018-01
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:
The purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure IOP at Week 4
Detailed Description:
Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration then undergo 2 eligibility visits Eligible subjects will be randomized 11 to receive masked SIMBRINZA or Vehicle for 4 weeks Two 24-hour visits will be conducted Day 0 and Week 4 during which intraocular pressure will be collected every 2 hours The expected duration of subject participation in the study is 10 weeks
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