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

NCT00972426 | Completed Phase 4

• 1 other identifier: 001-TWB-0901(n)
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• The change value of Intra-Ocular Pressure (IOP) in study group

  assessment will be done every month for 2 months for each subject

Secondary Outcomes (3)

• 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

Study Arms (2)

Treatment A Group

EXPERIMENTAL

Mikelan LA + Xalatan

Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)

Treatment B Group

ACTIVE COMPARATOR

Timoptol XE + Xalatan

Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)

Interventions

carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan) DRUG

Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks

Treatment A Group; Treatment B Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Hypersensitivity to either oral or topical beta-blocker therapy or to any ophthalmic solution used in the study;
• Patients wearing contact lenses;
• Patients with severe dry eyes;
• Patients who had ophthalmic surgery including cataract surgery, trabeculotomy or trabeculectomy within three months of study start;
• Patients who had laser trabeculoplasty within 2 months before starting study;
• Patients who had corneal contamination, and acute ophthalmic infection, or inflammatory ophthalmic disorder 2 months before starting study;
• Patients who had herpetic keratitis or corneal ulcer within 2 months before starting study;
• Patient who are receiving systemic administration of drugs that may have and effect on IOP;
• Patients who have poorly controlled heart failure, sinus bradycardia, atrioventricular block (1 and 2 grade), or cardiogenic shock;
• Patients with brochial asthma, bronchospasm or severe chronic obstructive pulmonary disease or a history thereof;
• Patients with poorly controlled diabetes or diabetic ketoacidosis or metabolic acidosis;
• Patients with aortic stenosis, Raynaud's syndrome, intermittent claudication, or pheochromocytoma;
• Patients with myasthenia gravis;
• Patients with severe hepatic or renal disorder judged by investigator;
• Patients who have confirmed or potential pregnancy, current lactation, or wish to become pregnant during the study period;

Sponsors & Collaborators

• Taiwan Otsuka Pharm. Co., Ltd: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Carteolol; Timolol; Latanoprost

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Morpholines; Oxazines; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Da-Wen Lu, MD/PhD

  Department of Opthalmology/ Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: September 7, 2009
• Study Start: October 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 5, 2011

Record last verified: 2011-09

Locations

TW (1)