Combigan Ophthalmic Solution(Brimonidine 0.2% and Timolol 0.5%)With Latanoprost Compared With Latanoprost Monotherapy
Information source: Genovate Biotechnology Co., Ltd.,
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma
Intervention: Combigan Ophthalmic Solutiom (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Genovate Biotechnology Co., Ltd., Official(s) and/or principal investigator(s):
Da-Wen Lu, Principal Investigator, Affiliation: Tri-Service General Hospital, Taiwan ROC
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
Primary outcome: The change of IntraOcular Pressure From baseline to week 12
Secondary outcome: The change of IntraOcular Pressure on week 8.The change of IntraOcular Pressure on week 12
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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Allergan, Taipei, Taiwan
Additional Information
Starting date: May 2006
Last updated: February 28, 2007
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