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| Sponsor: | Taiwan Otsuka Pharm. Co., Ltd |
|---|---|
| Information provided by (Responsible Party): | Taiwan Otsuka Pharm. Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT00972426 |
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 IV |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Taiwan | |
| Tri-Service General Hospital | |
| Taipei, Taiwan | |
| Principal Investigator: | Da-Wen Lu, MD/PhD | Department of Opthalmology/ Tri-Service General Hospital |
More Information
| 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 |
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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 |