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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

Information source: Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma

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

Phase: Phase 4

Status: Completed

Sponsored by: Taiwan Otsuka Pharm. Co., Ltd

Official(s) and/or principal investigator(s):
Da-Wen Lu, MD/PhD, Principal Investigator, Affiliation: Department of Opthalmology/ Tri-Service General Hospital

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.

Clinical Details

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

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

Primary outcome: The change value of Intra-Ocular Pressure (IOP) in study group

Secondary outcome:

The change value of IOP between groups

The change percentage of IOP in each group

The change of score of Patient satisfaction in each group

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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)

Locations and Contacts

Tri-Service General Hospital, Taipei, Taiwan
Additional Information

Starting date: October 2009
Last updated: September 1, 2011

Page last updated: August 23, 2015

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