Safety and eye pressure lowering effect of Brinz/Brim eye drops , compared to Brinzolamide and Brimonidine given separately in patients with increased eye pressure (ocular hypertension) or with associated changes to the nerve inside the eye (glaucoma).

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 525

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 already on
multiple IOP-lowering medications.
2. Patients should be able to understand and sign an informed
consent that has been approved by an Institutional Review
Board/Independent Ethics Committee.
3. 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 275
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

1. Females of childbearing potential (those who are not surgically
sterilized or post-menopausal for at least 1 year) are excluded
from participation in the studyif they meet any one of the
following conditions:
a. are currently pregnant or,
b. have a positive result on the urine pregnancy test at the
Screening Visit or,
c. intend to become pregnant during the study period or,
d. are breast-feeding or,
e. they are not using highly effective birth control measures,
such as:
Hormonal –
oral, implanted, transdermal, or injected
contraceptives;
Mechanical –
spermicide in conjunction with a barrier such
as a condom or diaphragm or IUD.
Patients with Schaffer angle Grade < 2, as measured by
gonioscopy (extreme narrow angle with complete or partial
closure).
3. Patients with a cup/disc ratio (C/D) greater than 0.80
(horizontal or vertical measurement).
4. Patients with 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 discontinue use of all IOPlowering
ocular medication(s) for a minimum period of 5 days
± 1 day to 28 days ± 1 day prior to Eligibility 1 (E1) Visit.
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 20/80 Snellen,
0.60 logMAR, or 0.25 decimal).
11. Other ocular pathology (including severe dry eye) that may, in
the opinion of the Investigator, preclude the administration of
alpha-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 alpha-adrenergic agonist or
CAI in the opinion of the investigator.
17. Patients with recent (within 4 weeks of the Eligibility 1 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 inhibitor.
20. Therapy with another investigational agent within 30 days
prior to the Screening Visit.
21. Hypersensitivity to alpha-adrenergic agonist drugs, topical or
oral CAIs, sulfonamide derivatives, or to any component of
the study medications in the opinion of the Investigator.
22. 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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