Status:
COMPLETED
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
Lead Sponsor:
Taiwan Otsuka Pharm. Co., Ltd
Conditions:
Glaucoma
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00972426
Start Date
October 1 2009
End Date
August 1 2010
Last Update
September 5 2011
Active Locations (1)
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1
Tri-Service General Hospital
Taipei, Taiwan