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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972426
• Other study ID #: 001-TWB-0901(n)
• Status: Completed
• Phase: Phase 4
• First received: August 20, 2009
• Last updated: September 1, 2011
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2011
• Source: Taiwan Otsuka Pharm. Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Otsuka Pharm. Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change value of Intra-Ocular Pressure (IOP) in study group		assessment will be done every month for 2 months for each subject	No
Secondary	The change value of IOP between groups		assessment will be done every month for 2 months for each subject	No
Secondary	The change percentage of IOP in each group		assessment will be done every month for 2 months for each subject	No
Secondary	The change of score of Patient satisfaction in each group		assessment will be done every month for 2 months for each subject	No