Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-05 @ 1:19 PM
Study NCT ID:
NCT03822559
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2019-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of DE-111A on the Treatment of Open Angle Glaucoma or Ocular Hypertension
Sponsor:
Santen Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-masked, Controlled Parallel Group, Multi-center Study of DE-111A (Fixed Dose Combination of Tafluprost and Timolol Eye Drops) on the Treatment of Open Angle Glaucoma or Ocular Hypertension (With Tafluprost Eye Drops as a Comparator)
Status:
COMPLETED
Status Verified Date:
2023-07
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:
The objective of this study is to investigate whether the IOP (intraocular pressure) -lowering effect of DE-111A (preservative-free fixed dose combination of 0.0015% tafluprost and 0.5% timolol eye drops, administered one drop a time, once daily for 3 months) is superior to the monotherapy of tafluprost 0.0015% eye drops administered one drop a time, once daily for 3 months) in subjects with open-angle glaucoma or ocular hypertension in China as well as comparison of safety.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: