Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-10 @ 6:10 AM
Study NCT ID:
NCT02325518
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2014-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Intraocular Pressure (IOP)-Lowering Efficacy and Safety of AZORGA® Ophthalmic Suspension and COSOPT® Ophthalmic Solution
Sponsor:
Alcon, a Novartis Company
Organization:
Study Overview
Official Title:
The Efficacy and Safety of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 1%/Timolol 0.5% in Patients With Open-Angle Glaucoma and Ocular Hypertension
Status:
COMPLETED
Status Verified Date:
2016-10
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 AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.
Detailed Description:
After the screening examination, subjects were enrolled in the study and moved into the observation period. During the observation period, prostaglandin-analog (PGA) monotherapy was applied. After the observation period of 4 weeks or more, the baseline examination was performed. Subjects were then randomized and moved into the treatment period.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UMIN000017569 | REGISTRY | UMIN | View |