Back to resultsA 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
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
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)
Sites / Locations
- Tri-Service General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment A Group
Treatment B Group
Arm Description
Mikelan LA + Xalatan
Timoptol XE + Xalatan
Outcomes
Primary Outcome Measures
The change value of Intra-Ocular Pressure (IOP) in study group
Secondary Outcome Measures
The change value of IOP between groups
The change percentage of IOP in each group
The change of score of Patient satisfaction in each group
Full Information
NCT ID
NCT00972426
First Posted
August 20, 2009
Last Updated
September 1, 2011
Sponsor
Taiwan Otsuka Pharm. Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00972426
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiwan Otsuka Pharm. Co., Ltd
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment A Group
Arm Type
Experimental
Arm Description
Mikelan LA + Xalatan
Arm Title
Treatment B Group
Arm Type
Active Comparator
Arm Description
Timoptol XE + Xalatan
Intervention Type
Drug
Intervention Name(s)
carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
Intervention Description
Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks
Primary Outcome Measure Information:
Title
The change value of Intra-Ocular Pressure (IOP) in study group
Time Frame
assessment will be done every month for 2 months for each subject
Secondary Outcome Measure Information:
Title
The change value of IOP between groups
Time Frame
assessment will be done every month for 2 months for each subject
Title
The change percentage of IOP in each group
Time Frame
assessment will be done every month for 2 months for each subject
Title
The change of score of Patient satisfaction in each group
Time Frame
assessment will be done every month for 2 months for each subject
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Da-Wen Lu, MD/PhD
Organizational Affiliation
Department of Opthalmology/ Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
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
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