Open-angle glaucoma or ocular hypertension MedDRA version: 9.1 Level: SOC Classification code 10015919 Term: Eye disorders MedDRA version: 9.1 Level: LLT Classification code 10030348 Term: Open angle glaucoma MedDRA version: 9.1 Level: LLT Classification code 10030043 Term: Ocular hypertension
Conditions
Interventions
Product Name: Travoprost 40 micrograms/ml / Brinzolamide 10 mg/ml
Product Code: FID # 113061
Pharmaceutical Form: Eye drops, suspension
INN or Proposed INN: Travoprost + Brinzolamide
Current Sponsor c
Sponsors
Alcon Research Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Female of childbearing potential unless strict conditions are respected. Severe central visual field loss. Angle grade 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 ( 1 gram). Significant disturbances of wake-sleep rhythms and/or who consume hypnotic drugs on a regular basis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Italy
Outcome results
None listed