Open-angle glaucoma or Ocular hypertension MedDRA version: 9.1 Level: LLT Classification code 10030348 Term: Open angle glaucoma MedDRA version: 9.1 Level: PT Classification code 10030348 Term: Open angle glaucoma MedDRA version: 9.1 Level: SOC Classification code 10015919 Term: Eye disorders MedDRA version: 9.1 Level: LLT Classification code 10030043 Term: Ocular hypertension MedDRA version: 9.1 Level: PT Classification code 10030043 Term: Ocular hypertension MedDRA version: 9.1 Level: SO
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
CAS Number: 157283-68-6
Current Sp
Sponsors
Alcon Research, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of either sex and any race, 18 years of age or older, diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension. Patients inadequately controlled on a current stable (i.e., at least 4 weeks) IOP lowering medication. Inadequately controlled is defined as having a mean IOP = 18 mmHg in at least one eye at the Screening Visit. Patients must meet the following IOP entry criteria in at least one eye: For each qualifying eye, the mean IOP must be: = 24 mmHg and = 36 mmHg at the 9:00 time point at both Eligibility Visits 1 and 2, and = 21 mmHg and = 36 mmHg at the 11:00 and 16:00 time points at both Eligibility Visits 1 and 2.The same eye(s) must qualify at all qualifying time points at both Eligibility Visits 1 and 2. The mean IOP is the average of IOP measurements in the same eye. Patients must be able to discontinue use of all IOP-lowering medication(s) for a minimum period of 5 days to 28 days prior to Eligibility Visit 1. Patients must be on a stable dosing regimen of medications affecting IOP for at least 30 days prior to the Screening Visit and must not change the dosing regimen during the eligibility period 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: Females of childbearing potential (those who are not surgically sterilized or at least two years post-menopausal) are excluded from participation in the study Patients with any form of glaucoma other than open-angle glaucoma (with or without pigment dispersion or pseudo-exfoliation component) or confirmed ocular hypertension. Patients with iridocorneal angle Shaffer grade 1 gram daily) salicylate therapy. History of uncontrolled diabetes or hypoglycemic episodes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the IOP-lowering efficacy and the safety over 12 months, of morning or evening instillations of Travoprost / Brinzolamide versus COSOPT dosed in the morning and evening, in patients with open-angle glaucoma or ocular hypertension.;Secondary Objective: ;Primary end point(s): The primary efficacy parameter (end point) is mean IOP at the 9:00, 11:00 and 16:00 time points at Month 12. | — |
Countries
Belgium, Denmark, France, Germany, Italy, Poland, Spain, Sweden
Outcome results
None listed