primary open-angle glaucoma exfoliation glaucoma pigmentary glaucoma ocular hypertension MedDRA version: 9.1 Level: PT Classification code 10035015 Term: Pigmentary glaucoma MedDRA version: 9.1 Level: LLT Classification code 10030043 Term: Ocular hypertension MedDRA version: 9.1 Level: LLT Classification code 10037118 Term: Pseudoexfoliation glaucoma MedDRA version: 9.1 Level: LLT Classification code 10036719 Term: Primary open angle glaucoma
Conditions
Interventions
Trade Name: Azopt
Product Name: Azopt
Pharmaceutical Form: Eye drops, suspension
INN or Proposed INN: BRINZOLAMIDE
CAS Number: 138890627
Concentration unit: % percent
Concentration type: equal
Concent
Sponsors
Alcon Laboratories, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Must have a clinical diagnosis of ocular hypertension, primary open-angle, exfoliation, or pigment dispersion glaucoma in at least one eye (study eye). - Must have been treated with a prostaglandin agent alone or in combination with adjunctive drugs in fixed or unfixed combinations for a minimum of two weeks at Visit 1 and have an intraocular pressure of between 21 and 32 mm Hg inclusive in at least one eye and = 32 mm Hg in both eyes at Visit 1. - Must have an IOP between 19 and 32 mm Hg inclusive at the 8:00 AM measurement in at least one eye and = 32 mm Hg at all time points in both eyes at Visit 2. - Must have best corrected visual acuity of 6/30 (20/100 Snellen, 0.7 LogMAR) or better in each eye. 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: - Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Visit 1. - Women of childbearing potential - Any clinically significant, serious, or severe medical or psychiatric condition. - Participation in any other investigational study within 30 days prior to Visit 1. - Known medical history of allergy or sensitivity to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the Principal Investigator (sulfa or BAC allergy). - Concomitant administration of an oral carbonic anhydrase inhibitor. - Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 30 days prior to Visit 1 or an anticipated change in the dosage during the course of the study. - History of bronchial asthma, or chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. - A history of, or at risk for uveitis or cystoid macular edema (CME). - History of ocular herpes simplex. - Fuch’s corneal dystrophy, moderate to severe guttata, or a subjectively low endothelial cell count by slit lamp biomicroscopy. - Use of contact lenses, unless patients agree to remove them prior to instillation of study medication and wait a minimum of fifteen minutes following drug instillation before re-inserting the lenses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy of brinzolamide 1.0% (Azopt) compared to placebo administered twice daily when added to travoprost 0.004%/timolol 0.5% fixed combination administered each morning. ;Secondary Objective: The secondary objective is to compare the safety between the two treatment groups during randomized therapy.;Primary end point(s): IOP lowering efficacy | — |
Countries
Czech Republic, Slovenia
Outcome results
None listed