A Study to Evaluate Efficacy and Safety Effects Using Mikelan® LA Ophthalmic Solution (OS) 2% Versus Timoptol® XE Ophthalmic Solution (OS) 0.5% in Ocular Hypertension Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Parallel, Open-label Study to Evaluate Efficacy and Safety Effects Using Mikelan® LA Ophthalmic Solution (OS) 2% Versus Timoptol® XE Ophthalmic Solution (OS) 0.5% in Ocular Hypertension Patients

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or females outpatients with primary open-angle glaucoma or ocular hypertension; 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. Aged between ≧ 20 and ≦80 years old when giving informed consent to the study. Exclusion Criteria: Hypersensitivity to either oral or topical beta-blocker therapy or to any ophthalmic solution used in the study; Patients wearing contact lenses; Patients with severe dry eyes; Patients who had ophthalmic surgery including cataract surgery, trabeculotomy or trabeculectomy within three months of study start; Patients who had laser trabeculoplasty within 2 months before starting study; Patients who had corneal contamination, and acute ophthalmic infection, or inflammatory ophthalmic disorder 2 months before starting study; Patients who had herpetic keratitis or corneal ulcer within 2 months before starting study; Patient who are receiving systemic administration of drugs that may have and effect on IOP; Patients who have poorly controlled heart failure, sinus bradycardia, atrioventricular block (1 and 2 grade), or cardiogenic shock; Patients with brochial asthma, bronchospasm or severe chronic obstructive pulmonary disease or a history thereof; Patients with poorly controlled diabetes or diabetic ketoacidosis or metabolic acidosis; Patients with aortic stenosis, Raynaud's syndrome, intermittent claudication, or pheochromocytoma; Patients with myasthenia gravis; Patients with severe hepatic or renal disorder judged by investigator; Patients who have confirmed or potential pregnancy, current lactation, or wish to become pregnant during the study period; Patients who have treatment with any investigational drug when giving informed consent; Patients with significant alcohol, drug or medication abuse as judged by investigator; Patients whom investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complication)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A Group<br>Mikelan LA + Xalatan | Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)<br>* Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks<br>|
| Active Comparator: Treatment B Group<br>Timoptol XE + Xalatan | Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)<br>* Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |