24-hour IOP control with Travoprost / Brinzolamide fixed combination once-daily (QD)in the evening vs TRAVATAN - 24-hour IOP-lowering effect of Travoprost/Brinzolamide

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

18 yrs of age or older. Either Sex. Open-angle glaucoma or ocular hypertension. Patients inadequately controlled on a urrent stable (i.e., at least 4 weeks) IOP lowering medication. Mean IOP (at Eligibility Visit 9AM) >= 24 mmHg. Mean IOP (Screening, Eligibility, 24-hour baseline visit) <= 32 mmHg at any time-points. Able to discontinue use of all IOP-lowering medication(s) for a minimum period of 4 days to a maximum of 35 days prior to the 24-hour Baseline Visit.
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

Female of childbearing potential unless strict conditions are respected. Severe central visual field loss. Angle grade < 2. Cup/disc ratio > 0.8 in either eye. Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months. Intraocular surgery or history of ocular trauma within the past 6 months. Ocular laser surgery in either eye within the past 3 months. Best-corrected VA worse than 55 letters read. Any abnormality preventing reliable tonometry. Current chronic, recurrent or severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) in either eye that would affect the conduct of the study. History of or current clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment in either eye. Unable to discontinue glucorticoid 4 weeks prior to the study and not use during the study. Allergy/hypersensitivity to study medication. Less than 30 days stable dosing regimen of medications used on a chronic basis than may affect IOP. Patients likely to be put on any additional ocular or systemic ocular hypotensive medication during the course of the study. Oral CAI. Recent use (< 4 weeks prior to the study) of Aspirin (> 1 gram). Significant disturbances of wake-sleep rhythms and/or who consume hypnotic drugs on a regular basis.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect on mean nocturnal IOP of the fixed combination Travoprost/Brinzolamide dosed once-daily in the evening versus TRAVATAN dosed once-daily in the evening, in patients with open-angle glaucoma or ocular hypertension.;Secondary Objective: None;Primary end point(s): Mean nocturnal IOP (midnight, 3:00 and 6:00)

Secondary Outcome Measures