Glaucoma
Conditions
Brief summary
The primary objective of the clinical study is to evaluate the efficacy and safety for Mikelan LA eye drops 2% (once per day) of intra-ocular pressure decreased.
Interventions
DRUGcarteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks
Sponsors
Taiwan Otsuka Pharm. Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or females outpatients with primary open-angle glaucoma or ocular hypertension; 2. Subjects who have received Latanoprost at least 4 weeks, and in the end of screening period, subject's Intra-Ocular Pressure is ≧18mmHg (choice of one eyes is possible), or Investigator judges the reduction of IOP is insufficient of individual subject. 3. Aged between ≧ 20 and ≦80 years old when giving informed consent to the study.
Exclusion criteria
1. Hypersensitivity to either oral or topical beta-blocker therapy or to any ophthalmic solution used in the study; 2. Patients wearing contact lenses; 3. Patients with severe dry eyes; 4. Patients who had ophthalmic surgery including cataract surgery, trabeculotomy or trabeculectomy within three months of study start; 5. Patients who had laser trabeculoplasty within 2 months before starting study; 6. Patients who had corneal contamination, and acute ophthalmic infection, or inflammatory ophthalmic disorder 2 months before starting study; 7. Patients who had herpetic keratitis or corneal ulcer within 2 months before starting study; 8. Patient who are receiving systemic administration of drugs that may have and effect on IOP; 9. Patients who have poorly controlled heart failure, sinus bradycardia, atrioventricular block (1 and 2 grade), or cardiogenic shock; 10. Patients with brochial asthma, bronchospasm or severe chronic obstructive pulmonary disease or a history thereof; 11. Patients with poorly controlled diabetes or diabetic ketoacidosis or metabolic acidosis; 12. Patients with aortic stenosis, Raynaud's syndrome, intermittent claudication, or pheochromocytoma; 13. Patients with myasthenia gravis; 14. Patients with severe hepatic or renal disorder judged by investigator; 15. Patients who have confirmed or potential pregnancy, current lactation, or wish to become pregnant during the study period; 16. Patients who have treatment with any investigational drug when giving informed consent; 17. Patients with significant alcohol, drug or medication abuse as judged by investigator; 18. Patients whom investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complication)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change value of Intra-Ocular Pressure (IOP) in study group | assessment will be done every month for 2 months for each subject |
Secondary
| Measure | Time frame |
|---|---|
| The change value of IOP between groups | assessment will be done every month for 2 months for each subject |
| The change percentage of IOP in each group | assessment will be done every month for 2 months for each subject |
| The change of score of Patient satisfaction in each group | assessment will be done every month for 2 months for each subject |
Countries
Taiwan
Outcome results
None listed