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
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
This date has not been verified as actual or estimated.
Primary Completion
August 2010
Actual (reported)
Study Completion
August 2010
Actual (reported)
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Estimated enrollment
32 participants
Study completion date
August 2010
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
August 20, 2009
Actual (reported)
First Posted
September 7, 2009
Actual (reported)
Study Start
October 2009
Date type not reported
This date has not been verified as actual or estimated.
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.
You may not qualify if:
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;
+3 more criteria
Contact the study team to confirm eligibility.
Quinolones
Quinolines
Heterocyclic Compounds, 2-Ring
Heterocyclic Compounds, Fused-Ring
Heterocyclic Compounds
Thiadiazoles
Thiazoles
Sulfur Compounds
Azoles
Heterocyclic Compounds, 1-Ring
Morpholines
Oxazines
Prostaglandins F, Synthetic
Prostaglandins, Synthetic
Prostaglandins
Eicosanoids
Fatty Acids, Unsaturated
Fatty Acids
Lipids
Autacoids
Inflammation Mediators
Biological Factors
Study Completion
August 2010
Actual (reported)
Last Updated
September 5, 2011
Record last verified: 2011-09
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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