Switching from beta blocker monotherapy to either ganfort ? or cosopt ?. A three months, single-blind , parallel group, randomized clinical trial in ocular hypertension/primary open angle glaucoma. - Cos_Gan_PR/09

Conditions: Primary open angle glaucoma or ocular hypertensive patients, any level of intraocular pressure.
MedDRA version: 9.1Level: PTClassification code 10030348

Registration Number: EUCTR2010-018853-36-IT

Lead Sponsor: Prof. Stefano Gandolfi-Universita` degli studi di Parma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Diagnosis of poag and oh (at least in one eye) 2.patient on therapy with timolol 0.5% for at least 3 months 3.patient who has not reached the target iop as determined by the treating physician
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Age < 18 years 2.Beta blockers are contraindicated 3.Ocular condition that are of safety concern and that can interfere with the study results 4.Closed/barely open anterior chamber angles or history of acute angle closure 5.Ocular surgery or argon laser trabeculoplasty within the last three months 6.Ocular inflammation/infection occurring within three months prior to pre-trial visit 7.Neurovascular patients (including diabetic patients with neovascular glaucoma) 8.Concominant topical ocular medication that can interfere with study medication 9.Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions 10.Other abnormal condition or symptom preventing the patient from entering the trial, according to the investigator`s judgement 11.refractive surgery patients 12.women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing 13.Inability to adhere to treatment/visit plan

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the safety and efficacy of a prosta-timolol fixed combination with a cai-timolol fixed combination in patients already on beta-blockers monotherapy;Secondary Objective: Area-under curve (intraocular pressure - IOP);Primary end point(s): Intraocular pressure (diurnal phasing 8-12-16)

Secondary Outcome Measures