Efficacy and Safety of Brinzolamide 10 mg/ml / Brimonidine 2 mg/ml Eye Drops, Suspension Compared to Brinzolamide 10 mg/ml Eye Drops, Suspension plus Brimonidine 2 mg/ml Eye Drops, Solution in Patients with Open-Angle Glaucoma or Ocular Hypertension.

Phase 3

Completed

Conditions: raised intra-ocular pressure with optic nerve damage
raised intra-ocular pressure without optic nerve damage
10018307

Registration Number: NL-OMON36182

Lead Sponsor: Alcon Laboratories

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

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 <= 36 mmHg at the 9 AM time point and
• >= 21 mmHg and <= 36 mmHg at the 11 AM time point ,
at both Eligibility 1 and Eligibility 2 Visits, following wash-out of any IOP-lowering medication.
Mean IOP must not be > 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

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 < 2 as measured by gonioscopy (extreme narrow angle with complete or partial closure).
3. Cup/disc ratio (C/D) greater than 0.80 (horizontal or vertical measurement).
4. Severe central visual field loss. Severe central visual field loss is defined as a sensitivity of
less than or equal to 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation.
5. Patients who cannot safely undergo the initial wash-out period discontinuing all IOP-lowering ocular medication(s) for a minimum of 5 (± 1) to 28 (± 1) days prior to E1 Visit.
6. Chronic, recurrent or severe inflammatory eye disease (ie, scleritis, uveitis, herpes keratitis).
7. Ocular trauma within the past 6 months.
8. Ocular infection or ocular inflammation within the past 3 months.
9. Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
10. Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal).
11. Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of a-adrenergic agonist and/or topical carbonic anhydrase inhibitor (CAI).
12. Intraocular surgery within the past 6 months.
13. Ocular laser surgery within the past 3 months.
14. Any abnormality preventing reliable applanation tonometry.
15. Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
16. History of active, severe, unstable or uncontrolled cardiovascular (eg, coronary insufficiency, hypertension, Raynaud*s phenomenon, orthostatic hypotension, thromboangiitis obliterans), cerebrovascular (eg, cerebral insufficiency), hepatic, or renal disease that would preclude
the safe administration of a topical a-adrenergic agonist or CAI in the opinion of the investigator.
17. Recent (within 4 weeks of the E1 Visit) use of high-dose (>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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Efficacy:<br /><br>• Mean diurnal IOP Change from Baseline at Month 3 (patient IOP change from<br /><br>baseline averaged over the 9 AM and +2 hrs time points)</p><br>

Secondary Outcome Measures