Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00972426
Recruitment Status : Completed
First Posted : September 7, 2009
Last Update Posted : September 5, 2011
Sponsor:
Information provided by (Responsible Party):
Taiwan Otsuka Pharm. Co., Ltd

Tracking Information
First Submitted Date  ICMJE August 20, 2009
First Posted Date  ICMJE September 7, 2009
Last Update Posted Date September 5, 2011
Study Start Date  ICMJE October 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2009)
  • The change value of IOP between groups [ Time Frame: assessment will be done every month for 2 months for each subject ]
  • The change percentage of IOP in each group [ Time Frame: assessment will be done every month for 2 months for each subject ]
  • The change of score of Patient satisfaction in each group [ Time Frame: assessment will be done every month for 2 months for each subject ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks
Study Arms  ICMJE
  • Experimental: Treatment A Group
    Mikelan LA + Xalatan
    Intervention: Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
  • Active Comparator: Treatment B Group
    Timoptol XE + Xalatan
    Intervention: Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 4, 2009)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00972426
Other Study ID Numbers  ICMJE 001-TWB-0901(n)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taiwan Otsuka Pharm. Co., Ltd
Study Sponsor  ICMJE Taiwan Otsuka Pharm. Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Da-Wen Lu, MD/PhD Department of Opthalmology/ Tri-Service General Hospital
PRS Account Taiwan Otsuka Pharm. Co., Ltd
Verification Date September 2011

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