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
This study has been completed.
Sponsor:
Taiwan Otsuka Pharm. Co., Ltd
Information provided by (Responsible Party):
Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov Identifier:
NCT00972426
First received: August 20, 2009
Last updated: September 1, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma |
Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
Drug Information available for:
Timolol
Timolol maleate
Carteolol
Carteolol hydrochloride
Latanoprost
U.S. FDA Resources
Further study details as provided by Taiwan Otsuka Pharm. Co., Ltd:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The change value of IOP between groups [ Time Frame: assessment will be done every month for 2 months for each subject ] [ Designated as safety issue: No ]
- The change percentage of IOP in each group [ Time Frame: assessment will be done every month for 2 months for each subject ] [ Designated as safety issue: No ]
- The change of score of Patient satisfaction in each group [ Time Frame: assessment will be done every month for 2 months for each subject ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 32 |
| Study Start Date: | October 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment A Group
Mikelan LA + Xalatan
|
Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks
|
|
Active Comparator: Treatment B Group
Timoptol XE + Xalatan
|
Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972426
Locations
| Taiwan | |
| Tri-Service General Hospital | |
| Taipei, Taiwan | |
Sponsors and Collaborators
Taiwan Otsuka Pharm. Co., Ltd
Investigators
| Principal Investigator: | Da-Wen Lu, MD/PhD | Department of Opthalmology/ Tri-Service General Hospital |
More Information
No publications provided
| Responsible Party: | Taiwan Otsuka Pharm. Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT00972426 History of Changes |
| Other Study ID Numbers: | 001-TWB-0901(n) |
| Study First Received: | August 20, 2009 |
| Last Updated: | September 1, 2011 |
| Health Authority: | Taiwan: Institutional Review Board |
Additional relevant MeSH terms:
|
Glaucoma Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Timolol Carteolol Latanoprost Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013