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| Sponsor: | Taiwan Otsuka Pharm. Co., Ltd |
|---|---|
| Information provided by: | 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: | Treatment, Randomized, Open Label, Parallel Assignment |
| 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 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment A Group: Experimental
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
|
|
Treatment B Group: Active Comparator
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| Contact: Britt Ko | +886-2-25052868 ext 112 | Britt_Ko@otsuka.com.tw |
| Taiwan | |
| Tri-Service General Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Da-Wen Lu, MD/PhD +886 2 8792 3311 ext 17009 p310849@ms23.hinet.net | |
| Principal Investigator: | Da-Wen Lu, MD/PhD | Department of Opthalmology/ Tri-Service General Hospital |
More Information
| Responsible Party: | Taiwan Otsuka Pharm. Co., Ltd ( Edward Peng/CRD director ) |
| Study ID Numbers: | 001-TWB-0901(n) |
| Study First Received: | August 20, 2009 |
| Last Updated: | December 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00972426 History of Changes |
| Health Authority: | Taiwan: Institutional Review Board |
|
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Eye Diseases Physiological Effects of Drugs Vascular Diseases Cardiovascular Agents Antihypertensive Agents Latanoprost Pharmacologic Actions |
Glaucoma Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Anti-Arrhythmia Agents Timolol Hypertension Ocular Hypertension |