raised intra-ocular pressure with optic nerve damage raised intra-ocular pressure without optic nerve damage
Conditions
Interventions
None listed
Sponsors
Alcon Laboratories
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patients 18 years of age or older, of either gender, and any race/ethnicity, diagnosed with open-angle glaucoma or ocular hypertension who in the opinion of the investigator are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications. 2) Mean IOP measurements in at least one eye, the same eye(s), must be: • >= 24 mmHg and = 21 mmHg and 36 mmHg at any time point. 3) Must be able to understand and sign an informed consent form that has been approved by an Independent Ethics Committee
Exclusion criteria
Exclusion criteria: 1. Women of childbearing potential (who are not postmenopausal for at least 1 year or surgically sterile) are excluded from participation if they are currently pregnant, have a positive result on the urine pregnancy test at Screening, or intend to become pregnant during the study period; are breast-feeding; are not in agreement to use adequate birth control methods (see the Manual of Procedures) to prevent pregnancy throughout the study. 2. Schaffer angle Grade 1 g daily) salicylate therapy. 18. Current or anticipated treatment with any psychotropic drugs that augment adrenergic response (eg, desipramine, amitriptyline). 19. Concurrent use of monoamine oxidase inhibitors (MAOI). 20. Concurrent use of glucocorticoids administered by any route. 21. Therapy with another investigational agent within 30 days prior to the Screening Visit. 22. Hypersensitivity to a-adrenergic agonist drugs, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications in the opinion of the Investigator. 23. Less than 30 days stable dosing regimen before the Screening Visit of any medications or substances administered by any route and used on a chronic basis that may affect IOP, including but not limited to β-adrenergic blocking agents. 24. Use of any additional topical or systemic ocular hypotensive medication during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy: • Mean diurnal IOP Change from Baseline at Month 3 (patient IOP change from baseline averaged over the 9 AM and +2 hrs time points) | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary efficacy endpoints. | — |
Countries
Netherlands
Outcome results
None listed