Comparison of Safety and Efficacy of Brinzolamide/Timolol Fixed Combination vs COSOPT® in Patients with Open-Angle Glaucoma or Ocular Hypertension. - Brinzolamide/Timolol Fixed Combination vs COSOPT

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 420

Inclusion Criteria

1) Patients, 18 years of age or older, diagnosed with open-angle glaucoma or ocular hypertension who are currently on an IOP-lowering medication and, in the opinion of the investigator, would benefit from a combination therapy.
2) Patients must meet the following IOP entry criteria in at least one eye: the mean IOP must be 24 to 36 mmHg at 8:00 AM; 21 to 36 mmHg at 10:00 AM at both Eligibility Visits 1 and 2.
3) Only patients who satisfy all informed consent requirements may be included in the study.

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) Patients who are intolerant or insufficiently responsive to COSOPT® as documented in their medical history.
2) History of chronic, recurrent or current severe inflammatory eye disease in either eye.
3) History of ocular trauma or intraocular surgery within the past 6 months.
4) History of or current ocular infection or ocular inflammation or ocular laser surgery within the past 3 months.
5) History of or current clinically significant or progressive retinal disease.
6) Patients with best- corrected visual acuity worse than 0.60 logMAR score in either eye.
7) Patients with severe central visual field loss in either eye.
8) Patients who cannot safely discontinue use of all ocular IOP-lowering medication(s) for a minimum period of 5 ±1day to 28 ±1day prior to Eligibility 1 visit.
9) History of or current severe, unstable or uncontrolled cardiovascular, hepatic or renal disease, bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
10) History of spontaneous or current hypoglycemia or uncontrolled diabetes.
11) Patients with less than 30 days stable dosing regimen before the Screening Visit of any medications or substances administered by any route and used on a chronic basis that may affect IOP.

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 IOP-lowering efficacy of Brinzolamide 1,0%/<br>Timolol 0,5 % Ophthalmic Suspension to COSOPT® in patients with open-angle glaucoma or ocular hypertension. <br>;Secondary Objective: ;Primary end point(s): The primary statistical objective of this study is to demonstrate that the IOP-lowering efficacy of Brinzolamide 1.0%/Timolol 0.5% Ophthalmic Suspension, dosed twice daily at 8:00 AM and 8:00 PM, is non-inferior to that of COSOPT, dosed twice daily at 8:00 AM and 8:00 PM. <br>

Secondary Outcome Measures

Name	Time	Method

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