Overview

Latanoprost/Brinzolamide BID Versus Latanoprost BID in Patients With OAG or OH

Status:
Withdrawn
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study is a double-masked, randomized, parallel group study in patients with open angle glaucoma or ocular hypertension. The aim of this study is to verify the efficacy of the fixed combination of Latanoprost 50 mcg / mL / brinzolamide 10mg/ml eye drops compared to Latanoprost 50μg/mL eye drops in reducing IOP
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Adapt Produtos Oftalmológicos Ltda.
Treatments:
Brinzolamide
Latanoprost
Ophthalmic Solutions
Criteria
Inclusion Criteria:

- Patients 18 years of age or older, of either gender and of any race / ethnicity,
diagnosed with open angle glaucoma or ocular hypertension, which in the opinion of the
investigator does not have enough control with monotherapy or already receiving
multiple medications for lowering IOP .

- Patients should be able to understand and sign an informed consent form that has been
approved by an Institutional Review Board.

- Measurements of mean IOP in at least 1 eye:

- ≥ 24 mmHg and ≤ 36 mmHg at timepoint 9am and

- ≥ 21 mmHg and ≤ 36 mmHg in the 11h timepoint in both Visits Eligibility 1 and
after washout of any medication to reduce IOP.

- The mean IOP should not be> 36 mmHg at any timepoint

Exclusion Criteria:

- Fertile women (those not surgically sterile or postmenopausal for at least 1 year) are
excluded from study participation if meet any of the following conditions:

1. currently pregnant or

2. have tested positive in urine pregnancy Screening Visit or

3. planning to become pregnant during the study period, or

4. are breastfeeding, or not using highly effective contraceptive precautions.

- Patients with angle Schaffer Grade <2, as measured by gonioscopy (extreme narrow angle
with complete or partial closure).

- Patients with a ratio cup / disc greater than 0.80 (horizontal or vertical).

- Patients presenting with loss of central visual field impairment. The loss of central
visual field is defined as a serious sensitivity less than or equal to 10 dB in at
least four points of two visual field test closest to the point of attachment.

- Patients who can not safely discontinue use of all medications to ocular IOP reduction
for a minimum of 5 days ± 1 day to 28 days ± 1 day prior to Visit E1.

- Chronic inflammatory eye disease, recurrent or severe (ie, scleritis, uveitis,
herpetic keratitis).

- Ocular trauma in the past 6 months.

- Eye infection or inflammation of the eye in the last 3 months.

- Retinal disease as clinically significant or progressive retinal degeneration,
diabetic retinopathy or retinal detachment.

- Best score corrected visual acuity (BCVA) worse than 55 ETDRS letters (equivalent to
approximately 20/80 Snellen).

- Another ocular pathology (including severe dry eye) that may, in the opinion of the
investigator, preventing the administration of an alpha-adrenergic agonist and/or an
inhibitor of topical carbonic anhydrase (CAI).

- Intraocular surgery within the last 6 months.

- Laser eye surgery in the last 3 months.

- Any abnormality that prevents a reliable applanation tonometry.

- Any other condition including severe illness that would make the patient, in the
opinion of the investigator, unsuitable for the study.

- History of cardiovascular disease (eg, coronary heart disease, hypertension, Raynaud's
phenomenon, orthostatic hypotension, thromboangiitis), cerebrovascular (eg, cerebral
insufficiency), active liver or kidney, severe, unstable or uncontrolled that would
prevent the safe administration of an alpha-adrenergic topic or CAI in the opinion of
the investigator.

Related to previous or concomitant medications

- Patients with recent use (within 4 weeks of Visit Eligibility 1) salicylate therapy
with high dose (> 1 g daily).

- Current or planned treatment with any psychotropic drug that increases the adrenergic
response (eg, desipramine, amitriptyline).

- Concomitant use of monoamine oxidase inhibitors.

- Therapy with another investigational agent within 30 days prior to the Screening
Visit.

- Hypersensitivity to the drug alpha-adrenergic agonists, oral or topical CAIs,
sulfonamide derivatives or any component of the study drugs in the opinion of the
investigator.

- Less than 30 days regimen with stable administration before the Screening Visit any
medications or substances administered by any route and used chronically that may
affect IOP, including among others, β-adrenergic blocking agents.

- Use of ocular hypotensive medication any additional topical or systemic throughout the
study.

- Concomitant use of glucocorticoids administered by any route.