Open Angle Glaucoma or Ocular Hypertension ICD: H40.1/H40.0
Conditions
Interventions
Product Name: Brinzolamide 10 mg/ml /Timolol 5 mg/ml Eye Drops/Suspension
Pharmaceutical Form: Eye drops, suspension
INN or Proposed INN: Brinzolamide
CAS Number: 138890-62-7
Current Sponsor code: AL-
Sponsors
Alcon Research, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective:to compare the safety and IOP-lowering efficacy of Brinzolamide 1,0%/ Timolol 0,5 % Ophthalmic Suspension to COSOPT® in patients with open-angle glaucoma or ocular hypertension. ;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. | — |
Countries
Italy, Latvia, Lithuania, Sweden, United Kingdom
Outcome results
None listed