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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 is currently recruiting participants.
Study NCT00972426   Information provided by Taiwan Otsuka Pharm. Co., Ltd
First Received: August 20, 2009   Last Updated: December 15, 2009   History of Changes

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)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
32
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or females outpatients with primary open-angle glaucoma or ocular hypertension;
  2. 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.
  3. Aged between ≧ 20 and ≦80 years old when giving informed consent to the study.

Exclusion Criteria:

  1. Hypersensitivity to either oral or topical beta-blocker therapy or to any ophthalmic solution used in the study;
  2. Patients wearing contact lenses;
  3. Patients with severe dry eyes;
  4. Patients who had ophthalmic surgery including cataract surgery, trabeculotomy or trabeculectomy within three months of study start;
  5. Patients who had laser trabeculoplasty within 2 months before starting study;
  6. Patients who had corneal contamination, and acute ophthalmic infection, or inflammatory ophthalmic disorder 2 months before starting study;
  7. Patients who had herpetic keratitis or corneal ulcer within 2 months before starting study;
  8. Patient who are receiving systemic administration of drugs that may have and effect on IOP;
  9. Patients who have poorly controlled heart failure, sinus bradycardia, atrioventricular block (1 and 2 grade), or cardiogenic shock;
  10. Patients with brochial asthma, bronchospasm or severe chronic obstructive pulmonary disease or a history thereof;
  11. Patients with poorly controlled diabetes or diabetic ketoacidosis or metabolic acidosis;
  12. Patients with aortic stenosis, Raynaud's syndrome, intermittent claudication, or pheochromocytoma;
  13. Patients with myasthenia gravis;
  14. Patients with severe hepatic or renal disorder judged by investigator;
  15. Patients who have confirmed or potential pregnancy, current lactation, or wish to become pregnant during the study period;
  16. Patients who have treatment with any investigational drug when giving informed consent;
  17. Patients with significant alcohol, drug or medication abuse as judged by investigator;
  18. 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
Contact: Britt Ko +886-2-25052868 ext 112 Britt_Ko@otsuka.com.tw
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP