Combigan Ophthalmic Solution(Brimonidine 0.2% and Timolol 0.5%)With Latanoprost Compared With Latanoprost Monotherapy
Primary Purpose
Glaucoma
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Combigan Ophthalmic Solutiom
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Glaucoma focused on measuring Combigan
Eligibility Criteria
Inclusion Criteria:
- Male or female, of legal age of consent.
- Diagnosis of ocular hypertension (OHT) or glaucoma (incl. open angle glaucoma, chronic angle closure glaucoma, exfoliative glaucoma, pigmentary glaucoma or pseudophakic glaucoma) and requiring administration of IOP lowering eye drops.
- Written informed consent has been obtained.
- The patient can understand all study instructions, and is willing and able to comply with the schedule of visits and treatment.
- Patient has been administering latanoprost eye drops as monotherapy in affected eye(s) for at least 12 weeks according to the approved product labeling.
- Patient's Day 0 IOP > 18 mm Hg in the proposed study eye/s on established latanoprost therapy.
- Patients who have used COMBIGAN® Ophthalmic Solution in the past must not have been discontinued from using this medication due to adverse events or due to lack of efficacy.
- Day 0: negative urine pregnancy test for females of childbearing potential.
Exclusion Criteria:
- .Uncontrolled systemic disease (e.g., hypertension, diabetes).
- .Females who are pregnant, nursing, or planning a pregnancy, or females of childbearing potential who are not using a reliable means of contraception. A female is considered of child-bearing potential unless she is post-menopausal, without a uterus and/or both ovaries, or has a tubal-ligation.
- .Known allergy or hypersensitivity to the study medication or components.
- .Anticipated alteration of existing chronic therapy with agents which could have a substantial effect on IOP (including, but not necessarily limited to systemic adrenergic agents including beta-adrenergic blocking agents [e.g., propanolol, metoprolol, nadolol, timolol and atenolol]), substantial interaction with study medications, or interaction with study outcomes.
- .Corneal abnormalities that would preclude accurate IOP readings with an applanation tonometer.
- .Any other active ocular disease other than glaucoma or ocular hypertension (e.g., uveitis, ocular infections, or severe dry eye). However, patients with chronic mild blepharitis, cataract, age-related macular degeneration, or a background diabetic retinopathy can be enrolled at the discretion of the investigator.
- .Required chronic use of other ocular medications during the study other than the study medications. Occasional use of artificial tears or topical decongestants and/or antihistamine is acceptable. Use of these within 24 hours of a scheduled study visit is prohibited.
- .Ocular surgery within the past 3 months.
- .Current enrolment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
- .Patient has a condition or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study,
- .Day 0 - Significant ocular irritation.
Sites / Locations
- Allergan
Outcomes
Primary Outcome Measures
The change of IntraOcular Pressure From baseline to week 12
Secondary Outcome Measures
The change of IntraOcular Pressure on week 8.
The change of IntraOcular Pressure on week 12
Full Information
NCT ID
NCT00442312
First Posted
February 27, 2007
Last Updated
February 28, 2007
Sponsor
Genovate Biotechnology Co., Ltd.,
Collaborators
Allergan Medical
1. Study Identification
Unique Protocol Identification Number
NCT00442312
Brief Title
Combigan Ophthalmic Solution(Brimonidine 0.2% and Timolol 0.5%)With Latanoprost Compared With Latanoprost Monotherapy
Official Title
An Open Label,Switch Study of the Safety and Efficacy of Combigan Ophthalmic Solution(Brimonidine 0.2% and Timolol 0.5%)With Latanoprost Compared With Latanoprost Monotherapy in Patient With Glaucoma or Ocular Hypertension.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Genovate Biotechnology Co., Ltd.,
Collaborators
Allergan Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Combigan Ophthalmic Solution provides addition IOP loweringwhen combined with Latanoprost.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Combigan
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Combigan Ophthalmic Solutiom
Primary Outcome Measure Information:
Title
The change of IntraOcular Pressure From baseline to week 12
Secondary Outcome Measure Information:
Title
The change of IntraOcular Pressure on week 8.
Title
The change of IntraOcular Pressure on week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, of legal age of consent.
Diagnosis of ocular hypertension (OHT) or glaucoma (incl. open angle glaucoma, chronic angle closure glaucoma, exfoliative glaucoma, pigmentary glaucoma or pseudophakic glaucoma) and requiring administration of IOP lowering eye drops.
Written informed consent has been obtained.
The patient can understand all study instructions, and is willing and able to comply with the schedule of visits and treatment.
Patient has been administering latanoprost eye drops as monotherapy in affected eye(s) for at least 12 weeks according to the approved product labeling.
Patient's Day 0 IOP > 18 mm Hg in the proposed study eye/s on established latanoprost therapy.
Patients who have used COMBIGAN® Ophthalmic Solution in the past must not have been discontinued from using this medication due to adverse events or due to lack of efficacy.
Day 0: negative urine pregnancy test for females of childbearing potential.
Exclusion Criteria:
.Uncontrolled systemic disease (e.g., hypertension, diabetes).
.Females who are pregnant, nursing, or planning a pregnancy, or females of childbearing potential who are not using a reliable means of contraception. A female is considered of child-bearing potential unless she is post-menopausal, without a uterus and/or both ovaries, or has a tubal-ligation.
.Known allergy or hypersensitivity to the study medication or components.
.Anticipated alteration of existing chronic therapy with agents which could have a substantial effect on IOP (including, but not necessarily limited to systemic adrenergic agents including beta-adrenergic blocking agents [e.g., propanolol, metoprolol, nadolol, timolol and atenolol]), substantial interaction with study medications, or interaction with study outcomes.
.Corneal abnormalities that would preclude accurate IOP readings with an applanation tonometer.
.Any other active ocular disease other than glaucoma or ocular hypertension (e.g., uveitis, ocular infections, or severe dry eye). However, patients with chronic mild blepharitis, cataract, age-related macular degeneration, or a background diabetic retinopathy can be enrolled at the discretion of the investigator.
.Required chronic use of other ocular medications during the study other than the study medications. Occasional use of artificial tears or topical decongestants and/or antihistamine is acceptable. Use of these within 24 hours of a scheduled study visit is prohibited.
.Ocular surgery within the past 3 months.
.Current enrolment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
.Patient has a condition or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study,
.Day 0 - Significant ocular irritation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Da-Wen Lu
Organizational Affiliation
Tri-Service General Hospital, Taiwan ROC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergan
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Combigan Ophthalmic Solution(Brimonidine 0.2% and Timolol 0.5%)With Latanoprost Compared With Latanoprost Monotherapy
We'll reach out to this number within 24 hrs