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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov Identifier:
NCT00972426
First received: August 20, 2009
Last updated: September 1, 2011
Last verified: September 2011
  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 4

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

Resource links provided by NLM:


Further study details as provided by Taiwan Otsuka Pharm. Co., Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972426

Locations
Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taiwan Otsuka Pharm. Co., Ltd
Investigators
Principal Investigator: Da-Wen Lu, MD/PhD Department of Opthalmology/ Tri-Service General Hospital
  More Information

No publications provided

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 20, 2014