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 groupsThe 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
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