Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-29 @ 11:09 PM
Study NCT ID:
NCT01306461
Status:
COMPLETED
Last Update Posted:
2012-06-08
First Post:
2011-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations
Sponsor:
Santen Oy
Organization:
Study Overview
Official Title:
A Phase III, Randomized, Double-masked 6-month Trial to Compare the Efficacy and Safety of the Preservative-free Fixed-dose Combination of Tafluprost and Timolol Eye Drops to Those of Tafluprost and Timolol Eye Drops Given Concomitantly in Patients With Open Angle Glaucoma or Ocular Hypertension
Status:
COMPLETED
Status Verified Date:
2012-06
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 compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of tafluprost and timolol.
This study will enroll patients who have ocular hypertension or glaucoma.
The study schedule includes seven visits to the study site and three stages:
* washout of 5 days to 4 weeks depending on current glaucoma medication (if any)
* 6-month study treatment period
* 1-3 weeks post-study period
This study will enroll patients who have ocular hypertension or glaucoma.
The study schedule includes seven visits to the study site and three stages:
* washout of 5 days to 4 weeks depending on current glaucoma medication (if any)
* 6-month study treatment period
* 1-3 weeks post-study period
Detailed Description:
None
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?: