| August 20, 2009 |
| December 15, 2009 |
| October 2009 |
| September 2010 (final data collection date for primary outcome measure) |
| 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 ] |
| Same as current |
| Complete list of historical versions of study NCT00972426 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| 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 |
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. |
| |
| Phase IV |
| Interventional |
| Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Glaucoma |
| Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks |
- Treatment A Group: Experimental
Mikelan LA + Xalatan
Intervention: Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
- Treatment B Group: Active Comparator
Timoptol XE + Xalatan
Intervention: Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
|
| |
| |
| Recruiting |
| 32 |
| September 2010 |
| September 2010 (final data collection date for primary outcome measure) |
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)
|
| Both |
| 20 Years to 80 Years |
| No |
|
|
| Taiwan |
| |
| NCT00972426 |
| Edward Peng/CRD director, Taiwan Otsuka Pharm. Co., Ltd |
| 001-TWB-0901(n) |
| Taiwan Otsuka Pharm. Co., Ltd |
|
| Principal Investigator: |
Da-Wen Lu, MD/PhD |
Department of Opthalmology/ Tri-Service General Hospital |
|
|
| Taiwan Otsuka Pharm. Co., Ltd |
| December 2009 |