Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442312
Status:
UNKNOWN
Last Update Posted:
2007-03-01
First Post:
2007-02-27
Brief Title:
Combigan Ophthalmic SolutionBrimonidine 02 and Timolol 05With Latanoprost Compared With Latanoprost Monotherapy
Sponsor:
Genovate Biotechnology Co Ltd
Organization:
Genovate Biotechnology Co Ltd
Study Overview
Official Title:
An Open LabelSwitch Study of the Safety and Efficacy of Combigan Ophthalmic SolutionBrimonidine 02 and Timolol 05With Latanoprost Compared With Latanoprost Monotherapy in Patient With Glaucoma or Ocular Hypertension
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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 study is to evaluate the efficacy and safety of Combigan ophthalmic solution in combination with Latanoprost when the therapy is swiched from Latanoprost monotherapy in patient with Glaucoma or ocular hypertension
Hypothesis
1 Combigan Ophthalmic Solution provides addition IOP loweringwhen combined with Latanoprost
2 The treatment with Combigan Ophthalmic Solution has an acceptable safety profile as measured by ocular and systemic safety parameters
Hypothesis
1 Combigan Ophthalmic Solution provides addition IOP loweringwhen combined with Latanoprost
2 The treatment with Combigan Ophthalmic Solution has an acceptable safety profile as measured by ocular and systemic safety parameters
Detailed Description:
The purpose of this study is to comparethe efficacy and safety Ophthalmic Solution in combination with Latanoprost when the therapy is swiched from Latanoprost monotherapy in patient with Glaucoma or ocular hypertension
The study will be open label prospective multi-centered where patients will be swiched from Latanoprostmonotherapy to a combination therapy of Latanoprost with Combigan Ophthalmic Solution
The study will be open label prospective multi-centered where patients will be swiched from Latanoprostmonotherapy to a combination therapy of Latanoprost with Combigan Ophthalmic Solution
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