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NCT Number: NCT00972426

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tri-Service General Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or females outpatients with primary open-angle glaucoma or ocular hypertension;
  • 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.
  • Aged between ≧ 20 and ≦80 years old when giving informed consent to the study.

Exclusion criteria

  • Hypersensitivity to either oral or topical beta-blocker therapy or to any ophthalmic solution used in the study;
  • Patients wearing contact lenses;
  • Patients with severe dry eyes;
  • Patients who had ophthalmic surgery including cataract surgery, trabeculotomy or trabeculectomy within three months of study start;
  • Patients who had laser trabeculoplasty within 2 months before starting study;
  • Patients who had corneal contamination, and acute ophthalmic infection, or inflammatory ophthalmic disorder 2 months before starting study;
  • Patients who had herpetic keratitis or corneal ulcer within 2 months before starting study;
  • Patient who are receiving systemic administration of drugs that may have and effect on IOP;
  • Patients who have poorly controlled heart failure, sinus bradycardia, atrioventricular block (1 and 2 grade), or cardiogenic shock;
  • Patients with brochial asthma, bronchospasm or severe chronic obstructive pulmonary disease or a history thereof;
  • Patients with poorly controlled diabetes or diabetic ketoacidosis or metabolic acidosis;
  • Patients with aortic stenosis, Raynaud's syndrome, intermittent claudication, or pheochromocytoma;
  • Patients with myasthenia gravis;
  • Patients with severe hepatic or renal disorder judged by investigator;
  • Patients who have confirmed or potential pregnancy, current lactation, or wish to become pregnant during the study period;
  • Patients who have treatment with any investigational drug when giving informed consent;
  • Patients with significant alcohol, drug or medication abuse as judged by investigator;
  • Patients whom investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complication)

Treatment and study plan

carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)

Drug

Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks

Primary outcomes

  1. The change value of Intra-Ocular Pressure (IOP) in study group

    Time frame: assessment will be done every month for 2 months for each subject

Secondary outcomes

  1. The change value of IOP between groups

    Time frame: assessment will be done every month for 2 months for each subject

  2. The change percentage of IOP in each group

    Time frame: assessment will be done every month for 2 months for each subject

  3. The change of score of Patient satisfaction in each group

    Time frame: assessment will be done every month for 2 months for each subject

Sponsors and collaborators

Lead sponsor

Taiwan Otsuka Pharm. Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 7, 2009
Registry last updated
Sep 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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