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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change value of Intra-Ocular Pressure (IOP) in study group	assessment will be done every month for 2 months for each subject

Secondary Outcome Measures

Outcome Measure	Time Frame
The change value of IOP between groups	assessment will be done every month for 2 months for each subject
The change percentage of IOP in each group	assessment will be done every month for 2 months for each subject
The change of score of Patient satisfaction in each group	assessment will be done every month for 2 months for each subject

Collaborators and Investigators

• Sponsor: Taiwan Otsuka Pharm. Co., Ltd
• Investigators: Principal Investigator: Da-Wen Lu, MD/PhD, Department of Opthalmology/ Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: August 20, 2009
• First Submitted That Met QC Criteria: September 4, 2009
• First Posted (Estimate): September 7, 2009

Study Record Updates

• Last Update Posted (Estimate): September 5, 2011
• Last Update Submitted That Met QC Criteria: September 1, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Pharmaceutical Solutions; Sympatholytics; Ophthalmic Solutions; Timolol; Latanoprost; Carteolol
• Other Study ID Numbers: 001-TWB-0901(n)