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
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 April 21, 2014