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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiwan Otsuka Pharm. Co., Ltd
• Treatments: Carteolol; Latanoprost; Ophthalmic Solutions; Timolol

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)