Effect and safety of eyedrops containing two medicines (Brinzolamide 10 mg/ml/Brimonidine 2 mg/ml Eye Drops, Suspension) compared with the simultaneous use of the two medicines separately (Brinzolamide 10 mg/ml Eye Drops, Suspension plus Brimonidine 2 mg/ml Eye Drops, Solution) in patients with increased eye pressure (ocular hypertension) or with associated changes to nerve inside the eye (glaucoma).

Conditions: Patients with open-angle glaucoma or ocular hypertension
MedDRA version: 13.1Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2010-024513-31-HU

Lead Sponsor: Alcon Research, Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 820

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 1 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 E1 and E2 Visits. 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 Institutional Review Board/Independent Ethics Committee.
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 420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

General
1. Women pregnant, or intending to become pregnant during the study period; breast-feeding; not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
Related to disease/condition being investigated (either eye)
2. Schaffer angle Grade < 2 as measured by gonioscopy.
3. Cup/disc ratio (C/D) greater than 0.80.
4. Severe central visual field loss.
5. 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
Related to previous or current ocular disease/condition (either eye)
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 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.
Related to current non-ocular disease/condition
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, cerebrovascular, hepatic, or renal disease that would preclude the safe administration of a topical a-adrenergic agonist or CAI in the opinion of the investigator.
Related to previous or concomitant medications
17. Recent 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, ß-adrenergic blocking agents.
24. Use of any additional topical or systemic ocular hypotensive medication during the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to demonstrate that the fixed combination (BID) brinzolamide 10 mg/mL / brimonidine 2 mg/mL eyes drops, suspension is non-inferior to the unfixed combination (BID) brinzolamide 10 mg/mL eye drops, suspension plus brimonidine 2 mg/mL eyes drops, solution with respect to IOP-lowering efficacy. The primary efficacy endpoint is an assessment of 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 Objective: There are no secondary objectives;Primary end point(s): The primary efficacy endpoint is an assessment of mean diurnal IOP change from baseline at Month 3 (patient IOP change from baseline averaged over the 9 AM, and +2 Hrs time points).;Timepoint(s) of evaluation of this end point: Average other 9am and +2hrs time points.

Secondary Outcome Measures