Combigan Ophthalmic Solution(Brimonidine 0.2% and Timolol 0.5%)With Latanoprost Compared With Latanoprost Monotherapy

Glaucoma Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00442312
• Other study ID #: COM 003
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 27, 2007
• Last updated: February 28, 2007
• Start date: May 2006
• Est. completion date: November 2006

Study information

• Verified date: February 2007
• Source: Genovate Biotechnology Co., Ltd.,
• Contact: n/a
• Is FDA regulated: No
• Health authority: Joint Institutional Review Board:Taiwan
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Male or female, of legal age of consent.

2. 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.

3. Written informed consent has been obtained.

4. The patient can understand all study instructions, and is willing and able to comply with the schedule of visits and treatment.

5. Patient has been administering latanoprost eye drops as monotherapy in affected eye(s) for at least 12 weeks according to the approved product labeling.

6. Patient’s Day 0 IOP > 18 mm Hg in the proposed study eye/s on established latanoprost therapy.

7. 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.

8. Day 0: negative urine pregnancy test for females of childbearing potential.

Exclusion Criteria:

1. .Uncontrolled systemic disease (e.g., hypertension, diabetes).

2. .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.

3. .Known allergy or hypersensitivity to the study medication or components.

4. .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.

5. .Corneal abnormalities that would preclude accurate IOP readings with an applanation tonometer.

6. .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.

7. .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.

8. .Ocular surgery within the past 3 months.

9. .Current enrolment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.

10. .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,

11. .Day 0 - Significant ocular irritation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Combigan Ophthalmic Solutiom

Locations

Country	Name	City	State
Taiwan	Allergan	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Genovate Biotechnology Co., Ltd.,	Allergan Medical

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of IntraOcular Pressure From baseline to week 12
Secondary	The change of IntraOcular Pressure on week 8.
Secondary	The change of IntraOcular Pressure on week 12