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

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)

• Registration Number: NCT00972426
• Lead Sponsor: Taiwan Otsuka Pharm. Co., Ltd

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 available

Study Timeline

• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-09-04
• Study First Posted: 2009-09-07
• Study Start: 2009-10
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-01
• Last Update Posted: 2011-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A Group	carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)	Mikelan LA + Xalatan
Treatment B Group	carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)	Timoptol XE + Xalatan

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan