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

• Conditions: patients with a diagnosis of open-angle glaucoma or ocular hyperthension; MedDRA version: 9.1Level: LLTClassification code 10030348Term: Open angle glaucoma

• Registration Number: EUCTR2005-004766-16-IT
• Lead Sponsor: ALCON ITALIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

-written informed consent, availability to satisfy the requirements of the informed consent - Patients, 18 years of age or older, diagnosed with open-angle glaucoma with or without pseudoexfoliation or pigment dispersion component or ocular hypertension who are currently on an IOP-lowering medication and, in the opinion of the investigator, would benefit from a combination therapy. -Patients must meet the following IOP entry criteria in at least one eye For each qualifying eye, the mean IOP must be 24 to 36 mmHg at 8 00 AM at both Eligibility Visits 1 and 2. For each qualifying eye, the mean IOP must be 21 to 36 mmHg at 10 00 AM at both Eligibility Visits 1 and 2. The mean IOP in either eye at any time point during Eligibility Visits 1 and 2 must not be greater than 36 mmHg. The same eye s must qualify at both Eligibility Visits 1 and 2. -Patients who wear contact lenses will be allowed to participate in the study provided that the contact lenses are removed before instillation of study medication, and that the patient waits a minimum of 15 minutes following drug instillation before re-inserting the lenses. Patients who wear contact lenses will be instructed to wear or bring their glasses with them on study visit days. - Patients using nonprescription and/or prescription topical ophthalmic and/or systemic non-IOP lowering medications except for those in the Exclusion Criteria 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

- Females of childbearing potential are excluded if they meet any one of the following conditions They are currently pregnant or, They have a positive result on the urine pregnancy test at the Screening Visit or,they intend to become pregnant during the study period or,they are breast-feeding or,they are not using highly effective birth control measures. Patient who are chilbearing potential must consent to a urine pregnancy test at screening visit, at month 6 visit and at exit visit. - Patients with any form of glaucoma other than open-angle glaucoma with or without a pigment dispersion or pseudoexfoliation component or ocular hypertension. - Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Screening Visit. - History of chronic, recurrent or current severe inflammatory eye disease in either eye. - History of ocular trauma within the past six 6 months in either eye. - History of or current ocular infection or ocular inflammation within the past three 3 months in either eye. History of or current clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye. - History of or current other ocular pathology including severe dry eye , in either eye, that would preclude the safe administration of a sulfonamide analogue. - History of severe or serious hypersensitivity to timolol maleate, topical or oral carbonic anhydrase inhibitors, sulfonamide derivatives, or to any components of the study medications - Intraocular surgery within the past 6 months as determined by patient history and/or examination in either eye. - Ocular laser surgery within the past 3 months as determined by patient history and/or examination in either eye. -Any abnormality preventing reliable applanation tonometry of either eye. -Patients with best-corrected visual acuity worse than 0.60 logMAR score in either eye. - Patients with angle grade less than Grade 2 in either eye, as measured by gonioscopy extreme narrow angle with complete or partial closure The cup/disc ratio is measured on both the vertical and horizontal axis. Patients are excluded if the cup/disc ratio is greater than 0.80 in either eye on the horizontal or vertical measurement. - Patients with severe central visual field loss in either eye. Severe central visual field loss is defined as a sensitivity of less than or equal to 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation. - Patients who cannot safely discontinue use of all ocular IOP-lowering medication s for a minimum period of 5 days 1 day to twenty-eight 28 days 1 day prior to Eligibility 1 Visit. - Use of any additional topical or systemic ocular hypotensive medication during the study. - Recent within 4 weeks of the Eligibility 1 Visit use of high-dose 1 gram daily salicylate therapy. - History of spontaneous or current hypoglycemia or uncontrolled diabetes. -History of or current severe, unstable or uncontrolled cardiovascular, hepatic or renal disease that would preclude the safe administration of a topical beta-blocker. - History of or current bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. - Patients who cannot safely discontinue all glucocorticoid medications administered by any route. - Patients must have washed ou

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: N/A;Primary end point(s): To compare the safety and efficacy IOP- lowering efficacy of Brinzolamide 1.0 /Timolol 0.5 ophtalmic suspension to COSOPT in patients witha a diagnosis of open-angle glaucoma or ocular hypertension.;Main Objective: To compare the safety and efficacy IOP- lowering efficacy of Brinzolamide 1.0 /Timolol 0.5 ophtalmic suspension to COSOPT in patients witha a diagnosis of open-angle glaucoma or ocular hypertension.